On December 21, 2025 T-MAXIMUM Pharmaceutical reported that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase II clinical trial for the treatment of recurrent glioblastoma (rGBM). This milestone marks a significant breakthrough in addressing one of the most formidable challenges in oncology: developing effective allogeneic CAR-T therapies for solid tumors.

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"The FDA’s clearance of the IND for MT027 represents a strong validation of our strategic commitment to tackling the most challenging solid tumors," said Dr. Xiaoyun Shang, Founder and CEO of T-MAXIMUM Pharmaceutical. "This milestone is not only a small step for T-MAXIMUM, but a significant leap forward for the entire cell therapy field as we push into the ‘uncharted territory’ of solid tumor treatment. The successful development and advancement of MT027 is grounded in our deep understanding of immunology and our decisive investment in allogeneic cell-editing technologies. As a technology-driven company, T-MAXIMUM Pharmaceutical will continue to uphold a rigorous and pragmatic scientific approach, steadily advancing the clinical development of MT027. We remain committed to breaking new ground in the unexplored landscape of solid tumor cell therapy and using the power of science to win more time for patients."

About MT027

MT027 is an "off-the-shelf" allogeneic CAR-T product sourced from healthy donors and designed to target B7-H3 for the treatment of recurrent glioblastoma. As an allogeneic therapy, MT027 enables large-scale manufacturing and cryopreservation, allowing patients to receive treatment rapidly without the delays associated with autologous cell production—an advantage that can be critical for individuals facing fast-progressing and life-threatening diseases.

Unlike many industry peers relying on lentiviral or retroviral vectors, T-MAXIMUM Pharmaceutical has achieved a major advancement during the product’s transition to registration-oriented clinical development—establishing a fully non-viral gene-editing platform. This innovation enhances product safety while improving manufacturing precision and controllability, representing the next generation of cell therapy engineering.

CAR-T therapies have revolutionized treatment for hematologic malignancies; however, progress in solid tumors has been notably slower—particularly in glioblastoma, where the blood-brain barrier, intratumoral heterogeneity, and immunosuppressive microenvironment pose unique challenges. FDA IND clearance enabling MT027 to enter Phase II clinical evaluation represents a milestone step in advancing allogeneic CAR-T technology toward one of the most difficult solid tumor indications.

Leveraging its mature allogeneic technology platform, T-MAXIMUM Pharmaceutical is concurrently developing additional clinical programs targeting brain metastases and other solid tumors, further expanding its therapeutic pipeline.

About Glioblastoma

Glioblastoma (GBM) is among the most aggressive and lethal cancers of the central nervous system, often referred to as the "Mount Everest" of neurosurgery. Despite widespread adoption of the standard Stupp regimen, median overall survival remains only 14–16 months, with a five-year survival rate below 5%. For patients with recurrent glioblastoma, treatment options are even more limited, with median survival typically less than 6–9 months. There remains a profound unmet medical need in this area.

Since its founding, T-MAXIMUM Pharmaceutical has focused its research and development strategy on addressing these unmet needs, deliberately steering away from highly competitive hematologic indications to confront the formidable challenge of glioblastoma. This regulatory achievement validates the feasibility and potential of the company’s platform.

(Press release, T-MAXIMUM Pharmaceutical, DEC 21, 2025, View Source [SID1234661568])

On December 21, 2025 Jacobio Pharma (1167.HK,) reported that it has entered an agreement with AstraZeneca for its proprietary Pan-KRAS inhibitor JAB-23E73. AstraZeneca will receive exclusive development and commercialisation rights outside of China, while Jacobio and AstraZeneca will jointly develop and commercialise JAB-23E73 in China.

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Under the terms of the agreement, Jacobio will receive an upfront payment of US$100 million, and is eligible for additional development and commercial milestone payments of up to US$1.915 billion, as well as tiered royalties on net sales achieved outside of China. AstraZeneca will be responsible for all clinical development, regulatory submissions, and commercialization activities for JAB-23E73 outside of China.

Yinxiang Wang Ph.D., Chairman and Co-CEO of Jacobio Pharma, commented: "We are delighted to partner with AstraZeneca. This collaboration marks a significant step forward as we bring our world-class programs to the global stage and maximize the value of our R&D innovation. We are committed to providing breakthrough treatments and improving survival for patients, including those with KRAS-mutated cancers, across the world."

Matt Hellmann, Senior Vice President, Early Oncology and Precision Medicine, Oncology R&D, AstraZeneca, said: "KRAS is one of the most important oncogenes in cancer, with KRAS-mutated tumours driving profound unmet need for patients with pancreatic, colorectal and lung cancers. By advancing KRAS inhibitors like JAB-23E73, and in combination with our diverse oncology portfolio, we aim to accelerate the development of new treatment regimens that have the potential to transform outcomes for patients."

JAB-23E73 is an innovative Pan-KRAS inhibitor developed using Jacobio’s induced allosteric drug discovery platform, designed to target multiple KRAS mutation subtypes. KRAS is the most frequently mutated oncogene in human cancers, present in approximately 23% of all patients. JAB-23E73 is being evaluated in Phase I trials in both China and the United States, where early signs of anti-tumor activity have been observed.

This agreement strengthens Jacobio’s financial position, accelerates the global development efforts, and expands our presence in the global oncology innovation ecosystem.

Jacobio will continue to delve into the KRAS pathway, advance tADCs with KRAS inhibitors as payloads, develop differentiated drugs targeting more KRAS mutation types, and drive forward its next immuno-oncology programs, including our STING-based iADC platform.

(Press release, Jacobio Pharmaceuticals, DEC 21, 2025, View Source [SID1234661569])

On December 21, 2025 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

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"Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences."

Lunsumio VELO reduces administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

"This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma," said Dr. Ian Flinn, M.D., Ph.D., Tennessee Oncology and One Oncology. "With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings."

The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively. The median duration of response was 22.4 months (95% CI: 16.8–22.8). The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15). CRS can be severe and life-threatening.

Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorization of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Genentech continues to advance its bispecific antibody program in lymphoma, with ongoing Phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy (polatuzumab vedotin-piiq) in second-line or later large B-cell lymphoma , and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL.

Genentech is committed to helping patients get the medicine their doctor prescribed. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS/866-422-2377 or View Source

About the GO29781 Study

The GO29781 [NCT02500407] study is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab-axgb administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO was established on the basis of objective response rate and duration of response.

About Follicular Lymphoma (FL)

Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2025 and more than 110,000 people are diagnosed with FL each year worldwide.

About Lunsumio VELO (mosunetuzumab-axgb)

Lunsumio VELO is a subcutaneous formulation of mosunetuzumab-axgb, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications.

Lunsumio and Lunsumio VELO U.S. Indication

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

fever of 100.4°F (38°C) or higher
chills
low blood pressure
fast or irregular heartbeat
tiredness or weakness
difficulty breathing
headache
confusion
feeling anxious
dizziness or light-headedness
nausea
vomiting
Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a "step-up dosing schedule."

The step-up dosing schedule is when you receive smaller "step-up" doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the "step-up dosing schedule"
You may receive medicines to help reduce your risk of CRS before your dose
Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including:
headache
numbness and tingling of the arms, legs, hands, or feet
dizziness
confusion and disorientation
difficulty paying attention or understanding things
forgetting things or forgetting who or where you are
trouble speaking, reading or writing
sleepiness or trouble sleeping
tremors
loss of consciousness
seizures
muscle problems or muscle weakness
loss of balance or trouble walking
tiredness
Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including:
fever of 100.4°F (38°C) or higher
cough
chest pain
tiredness
shortness of breath
painful rash
sore throat
pain during urination
feeling weak or generally unwell
Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
fever
enlarged spleen
easy bruising
low blood cell counts
liver problems
Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection
low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO:
chest pain
cough
trouble breathing
tender or swollen lymph nodes
pain or swelling at the site of the tumor
Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects.

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you:

have ever had an infusion reaction after receiving LUNSUMIO
have an infection or have had an infection in the past which lasted a long time or keeps coming back
have or have had Epstein-Barr Virus
are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
Females who are able to become pregnant:

your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on View Source

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication
Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication
Side effects seen most often

The most common side effects during treatment were

Nerve problems in arms and legs
Nausea
Tiredness or lack of energy
Diarrhea
Constipation
Hair loss
Redness and sores of the lining of the mouth, lips, throat, and digestive tract
Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose
These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

You may report side effects to the FDA at (800) FDA-1088 or View Source You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and visit View Source for additional Important Safety Information.

(Press release, Genentech, DEC 21, 2025, View Source [SID1234661584])

On December 19, 2025 Tolmar, Inc. (Tolmar) reported that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Rubraca (rucaparib), enabling its use prior to chemotherapy for eligible patients with metastatic castration-resistant prostate cancer (mCRPC). The approval is supported by the pivotal TRITON3 Phase 3 trial, which demonstrated that Rubraca is the first and only PARP inhibitor to exceed the efficacy of docetaxel in a direct, head-to-head comparison, marking a significant evolution in treatment sequencing for patients with DNA damage repair (DDR)-deficient tumors.

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"This approval reflects a breakthrough moment for patients and for precision oncology," said Anil D’Souza, Chief Executive Officer of Tolmar. "For years, oncologists have relied on docetaxel as an important therapy in this setting. Now, TRITON3 has shown that Rubraca can not only move ahead of chemotherapy but outperform it—supported by clear genomic rationale and superior progression-free survival. Bringing Rubraca earlier in the treatment journey offers physicians a more targeted approach for patients with BRCA mutated prostate cancer."

The TRITON3 study is a Phase 3, multicenter, open-label, randomized trial of rucaparib in chemotherapy-naïve mCRPC patients who had been previously treated with an androgen receptor directed therapy. The study enrolled 405 patients with a mutation in BRCA or ATM who were randomized to rucaparib or the control group, which consisted of physician’s choice of docetaxel, abiraterone acetate, or enzalutamide. Approximately 55% of the patients in the control arm received docetaxel. The primary endpoint was radiographic progression-free survival (rPFS) by independent radiology review (IRR), in patients with mutations in BRCA1, BRCA2 or ATM. TRITON3 was designed as a Phase 3 trial to confirm and expand the efficacy data from TRITON2 in an earlier treatment setting in mCRPC against a relevant control arm. Patients were selected for therapy based on an FDA-approved companion diagnostic for rucaparib.

Key findings include:

Superiority in Radiographic Progression-Free Survival (rPFS):
Rubraca achieved a statistically significant improvement in rPFS vs. the control arm, delivering a median rPFS of 11.2 months vs. 6.4 months , HR 0.50
In a sub-analysis of Rubraca vs Docetaxel, the rPFS was 11.2 months vs. 8.3 months with docetaxel in the BRCA subgroup
Compelling Genomically Driven Benefit:
Patients with BRCA mutations demonstrated the strongest response, showing a ~50% reduction in risk of progression or death vs. docetaxel
Rubraca Tolerability Profile:
The safety profile of Rubraca observed in TRITON3 was consistent with previous studies. In TRITON3, the discontinuation rate for TEAEs was 14.8% for Rubraca-treated patients and 21.5% for the control arm
Prostate cancer is the most diagnosed cancer in U.S. men, with an estimated 313,780 new cases diagnosed in 2025.2 Approximately 10 to 20 percent of patients progress to castration-resistant prostate cancer, an incurable disease, within five years of diagnosis.3 The vast majority have metastases at diagnosis or develop metastases within two years.3 Of these, an estimated 13% have BRCA-mutated mCRPC,4 a disease characteristic associated with a poor prognosis.5 Men with mCRPC and the presence of a germline BRCA2 mutation, a prognostic marker, have more aggressive disease and poorer survival.6 While less common in prostate cancer, germline mutations in BRCA1 are also associated with more aggressive disease6. mCRPC generally responds to initial androgen deprivation therapy.7 However, most patients will inevitably develop treatment resistance.7

Rubraca (rucaparib) U.S. Prostate Cancer FDA-Approved Indication

INDICATION

RUBRACA (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 2141 treated patients with ovarian and prostate cancer, MDS/AML occurred in 34 patients (1.6%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.7%).
The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In ARIEL3, of patients with ovarian cancer associated with a germline and/or somatic BRCA mutation who were treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON3, MDS/AML occurred in 2 out of 201 patients (1%) with a BRCA mutation treated with RUBRACA. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.4 to 2.3 years.

Do not start RUBRACA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt RUBRACA or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue RUBRACA.

Based on findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of RUBRACA.

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥10%, Grade 1-4) were fatigue/asthenia (61%), musculoskeletal pain (53%), nausea (51%), decreased appetite (34%), diarrhea (31%), constipation (31%), vomiting (25%), dyspnea (19%), dysgeusia (18%), edema (18%), abdominal pain (17%), dizziness (16%), weight decreased (16%), rash (13%), headache (12%), peripheral neuropathy (12%), photosensitivity reaction (12%), and urinary tract infection (10%).

Most common select laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON3 (≥ 25%, Grade 1-4) were increased ALT (68%), decreased neutrophils (67%), decreased phosphate (64%), decreased hemoglobin (60%), increased AST (59%), increased creatinine (56%), increased glucose (45%), decreased lymphocytes (43%), decreased sodium (35%), decreased platelets (34%), and increased calcium (29%).

Most common adverse reactions of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), decreased appetite (28%), rash (27%), constipation (27%), vomiting (22%), and diarrhea (20%).
Most common laboratory abnormalities of patients with BRCA-mutated mCRPC treated with RUBRACA in TRITON2 (≥ 35%; Grade 1-4) were increased ALT (69%), decreased leukocytes (69%), decreased phosphate (68%), decreased absolute neutrophil count (62%), decreased hemoglobin (59%), increased alkaline phosphatase (44%), increased creatinine (43%), decreased lymphocytes (42%), increased triglycerides (42%), decreased platelets (40%), and decreased sodium (38%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

(Press release, Tolmar Pharmaceuticals, DEC 19, 2025, View Source [SID1234661564])

On December 19, 2025 Wasatch BioLabs (WBL), a leader in native, long-read sequencing and epigenomic analysis, reported a co-marketing agreement with Agilent Technologies to support the adoption of its Direct Targeted Methylation Sequencing (dTMS) platform. The collaboration brings together Agilent’s enrichment chemistries—SureSelect for genomic DNA and Avida for cell-free DNA—and WBL’s proprietary Oxford Nanopore-based native-read workflow, expanding access to scalable targeted multi-omic analysis for RUO and clinical research studies.

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The SureSelect and Avida capabilities both fill a critical gap in native-read sequencing by enabling precise, custom targeting up to 1 Mb, while preserving native DNA features such as methylation and structural variants. By eliminating off-target sequencing, DNA damage of traditional bisulfite-based methods, and biases introduced by PCR amplification, researchers can capture true biology across large and short, customized genomic regions. This opens new doors for liquid biopsy and targeted genomic applications with cost-efficient, scalable, and highly precise approaches suitable for a broad-array of research and screening applications.

"Multi-omic biology is essential for understanding disease, but for broad adoption it has to be delivered in a way that scales," said Dean Lilley, Senior Director of Product Development at Wasatch BioLabs. "Our alignment with Agilent ensures that native-read targeted sequencing delivers integrated genetic and epigenetic insight, while establishing the consistency, reproducibility, and operational reliability required for high-throughput research and potential future clinical translation.

Early adopters in oncology, neurology, rare disease, and prenatal research are already applying dTMS to resolve structural variation, allelic context, repeat expansions, and methylation patterns in a unified assay. These programs demonstrate how native-read targeted sequencing can support more comprehensive, mechanism-informed profiling across research areas such as liquid biopsy and large cohort studies.

"Partnering with Wasatch BioLabs allows Agilent to deliver a next-generation experience for customers who need both innovation and operational flexibility," said Nina Green, vice president and general manager of Agilent’s Clinical Diagnostics Division. "By integrating SureSelect and Avida enrichment with Wasatch’s novel sequencing technology and robust send-out service model, we are enabling customers to access high-quality NGS data without workflow barriers. This collaboration accelerates adoption, improves turnaround times, and provides a powerful, innovation-led path to achieving high-confidence genomic insights at any scale."

Under the agreement, WBL and Agilent will jointly deliver scientific content, educational programming, and technology demonstrations through 2027. The organizations anticipate the collaboration will scale adoption of native-read targeted sequencing and accelerate the development of cost-efficient, relevant native-read assays.

WBL welcomes additional partners interested in integrating the targeted sequencing assay into their research or development programs. The service will remain in early access through Q1 2026. Early adopters will have the opportunity to shape future enhancements and gain first access to new capabilities.

(Press release, Agilent, DEC 19, 2025, View Source [SID1234661565])