The results of the EMPRESS study show the activity of giredestrant in reducing tumor proliferation in ER+/HER2- breast cancer at early stages without the need for ovarian function suppression

On October 20, 2025 MEDSIR, the leading international oncology research company, reported the positive results of its EMPRESS study, conducted in collaboration with Roche Farma. This is an international, multicenter Phase II trial that evaluates the potential benefit of the drug giredestrant, a potent oral selective estrogen receptor degrader (SERD), in premenopausal women with early-stage ER+/HER2- breast cancer.

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The results, presented at the congress during an oral session, demonstrated that giredestrant, administered as a single agent in the preoperative setting, shows greater activity compared to standard treatment with tamoxifen in slowing the proliferation of tumor cells. The study met its primary endpoint by showing that, after 15 days of treatment, patients receiving giredestrant experienced a significant reduction in the tumor proliferation marker Ki-67. This protein appears in cells when they are dividing, so its reduction indicates a positive response to treatment.

One of the most relevant findings of the study is that, for the first time, this reduction in tumor activity is achieved without suppressing the patient’s ovarian function. This suggests that giredestrant could represent a more effective oral therapeutic alternative to the current standard therapy, with the potential to improve patients’ quality of life by avoiding the adverse effects associated with ovarian suppression, which is typically performed with injections of luteinizing hormone-releasing hormone (LHRH) analogs.

"The results of the EMPRESS study are very promising, as they indicate greater activity of giredestrant compared to tamoxifen in slowing tumor proliferation, as measured by Ki-67," said Dr. Antonio Llombart-Cussac, principal investigator of the study, during the presentation. He also emphasized that "this study opens the door to exploring the potential use of giredestrant without ovarian function suppression in premenopausal women, which could significantly improve patients’ quality of life by avoiding the side effects associated with traditional treatment."

Theranostics: The Revolution in Oncology

As part of the congress and its commitment to international collaboration and innovation, MEDSIR held a new edition of its MEDTalks forum in Berlin, supported by Telix Pharma. During the event, the company brought together leading national and international oncology experts, including Dr. Matthias Preusser (Medical University of Vienna), Dr. Nathalie Albert (Ludwig Maximilian University of Munich), Dr. Christophe Deroose (KU Leuven), and Dr. Jaume Capdevila (Vall d’Hebron Institute of Oncology, VHIO). The goal of this edition was to explore the crucial role of theranostics in optimizing cancer research.

Under the title "Understanding the Challenge in Clinical Trials," the discussion addressed the importance of implementing this new approach in oncology, which combines imaging-based diagnosis with precision therapy. This therapeutic strategy benefits patients in more advanced stages with limited treatment options through the administration of a radiopharmaceutical—first to visualize the tumor (diagnosis) and then to treat it (therapy).

MEDSIR Reinforces Its Commitment to Breast Cancer at ESMO (Free ESMO Whitepaper) 2025

In addition to the oral presentation of EMPRESS results, MEDSIR’s active participation in the ESMO (Free ESMO Whitepaper) congress includes the poster presentation of the TELESCOPE study. This ongoing national phase II clinical trial, conducted in collaboration with pharmaceutical company Merck Sharp & Dohme, evaluates the addition of pembrolizumab to carboplatin and paclitaxel treatment during 12 weeks prior to surgery for patients with stage I triple-negative breast cancer. The goal is to assess the pathological complete response (pCR) rate to preoperative treatment.

(Press release, MedSIR, OCT 20, 2025, View Source;breast-cancer-at-early-stages-without-the-need-for-ovarian-function-suppression-302588871.html [SID1234656829])

Citius Oncology Signs U.S. Distribution Agreement with McKesson to Support LYMPHIR™ Commercial Launch

On October 20, 2025 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported it has entered into a distribution services agreement with McKesson Corporation (NYSE: MCK), one of the largest pharmaceutical distributors and healthcare services companies in North America. Under the agreement, McKesson will serve as an authorized distributor of record for LYMPHIR (denileukin diftitox-cxdl), a novel immunotherapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

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The agreement with McKesson completes Citius Oncology’s core U.S. distribution network for LYMPHIR, which now includes all three of the largest pharmaceutical distributors in the country. This strategic milestone ensures broad and reliable access to the therapy in preparation for its planned commercial launch in the fourth quarter of 2025.

"This agreement marks the final major component of our U.S. distribution strategy and reflects our deep commitment to ensuring that physicians and patients have timely access to LYMPHIR," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "With a complete top-tier distribution network in place, we believe we are well-positioned to deliver on our promise to the CTCL community and execute a successful launch."

Headquartered in Irving, Texas, McKesson Corporation is a global leader in healthcare supply chain management, medical products distribution, and pharmaceutical logistics. The company supports thousands of hospitals, clinics, and pharmacies across the United States, making it a critical partner for enabling access to life-saving therapies like LYMPHIR.

Citius Oncology has now finalized distribution agreements with all three of the largest U.S. pharmaceutical wholesalers and specialty distributors, paving the way for broad national access across both academic centers and community oncology practices. These efforts complement the Company’s ongoing commercialization activities, including inventory readiness, market access infrastructure, permanent J-code assignment (J9161), NCCN guideline inclusion, and a robust suite of provider and patient education resources.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia. LYMPHIR was approved by the FDA in August 2024.

About Cutaneous T-cell Lymphoma

Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.

INDICATION

LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CAPILLARY LEAK SYNDROME

Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred.

Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

Visual Impairment

LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment.

Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4% [see Adverse Reactions (6.1)]. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion [see Dosage and Administration (2.3)]. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity [see Dosage and Administration (2.4)]. Institute appropriate medical management.

Hepatotoxicity

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved [see Adverse Reactions (6.1)]. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

Females and Males of Reproductive Potential

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

Contraception

Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . You may also report side effects to Citius Oncology, Inc. at 1-844-459-6744.

Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.

(Press release, Citius Oncology, OCT 20, 2025, View Source [SID1234656828])

BeOne Medicines Presents New Data on TEVIMBRA in Lung Cancer at ESMO 2025

On October 20, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA (tislelizumab), at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21. The results reinforce TEVIMBRA’s consistent and durable efficacy across lung cancer subtypes, including non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). In addition, the first clinical data from BeOne’s investigational HPK1 inhibitor, BGB-26808, as a single agent and in combination with TEVIMBRA, will be presented, highlighting promising antitumor activity and a generally manageable safety and tolerability profile in patients with advanced solid tumors.

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"The results presented at ESMO (Free ESMO Whitepaper) 2025 strengthen the evidence base for TEVIMBRA in lung cancer, with consistent survival benefit across subtypes. We’re also encouraged by clinical activity from our investigational HPK1 inhibitor, BGB-26808, which supports our TEVIMBRA-based combination strategy," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With TEVIMBRA’s recent European approval in perioperative resectable NSCLC and our diversified, combination-rich pipeline, we are advancing next-generation options for people with lung cancer."

New Data Builds on Strong Evidence Base for TEVIMBRA in Lung Cancer Treatment

The European Commission’s approvals of TEVIMBRA in lung cancer are based on five randomized Phase 3 studies from the RATIONALE program. At ESMO (Free ESMO Whitepaper) 2025, BeOne will present new data from two of these trials, further substantiating TEVIMBRA’s efficacy across lung cancer settings, including NSCLC and ES-SCLC, with a consistent safety profile.

RATIONALE-307 (NCT03594747): Long-term data show TEVIMBRA plus chemotherapy significantly improved overall survival over chemotherapy alone across different subgroups of patients with locally advanced or metastatic squamous NSCLC, including patients with stage IV disease, irrespective of PD-L1 expression. These survival benefits were observed even in the presence of high in-study crossover from chemotherapy to TEVIMBRA, a factor that typically reduces the observed benefit of treatment1. TEVIMBRA plus chemotherapy demonstrated a generally well-tolerated safety profile with no new safety signals even at the longer follow-up. The most common Grade 3 or 4 treatment-related adverse events (TRAEs) were associated with chemotherapy and included decreased neutrophil counts, neutropenia and leukopenia. (poster #1858, Oct. 18, 12:00-12:45 PM CEST).

A post-progression analysis from RATIONALE-307 also suggests that continued TEVIMBRA monotherapy may help extend survival in select patients whose disease progresses in a slower, more localized way (poster #1871​, Oct. 18, 12:00-12:45 PM CEST).
RATIONALE-312 (NCT04005716): Three-year data confirmed long-term efficacy and safety of first-line TEVIMBRA plus chemotherapy in ES-SCLC, with meaningful and sustained improvements in overall survival in both the intent-to-treat population and PD-L1-expressing subgroups, and no new safety signals identified. The most common Grade 3 or 4 TRAEs for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, and decreased white blood count (poster #2765, Oct. 18, 12:00-12:45 PM CEST).
Pipeline Momentum: Early Findings from HPK1 Inhibitor BGB-26808

Preliminary findings from the Phase 1a dose-escalation trial (NCT05981703) assessing BGB-26808, a novel, second-generation HPK1 inhibitor, as monotherapy and combined with TEVIMBRA showed encouraging antitumor activity in the combination arm. The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses. Safety was manageable in patients with advanced, metastatic, and unresectable solid tumors. Grade 3 or 4 TRAEs with single-agent BGB-26808 were reported in 21.8% of patients and in 21.2% of patients in the combination arm (poster #1564, Oct. 19, 12:00-12:45 PM CEST).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, OCT 20, 2025, View Source [SID1234656827])

Transgene and BioInvent’s Armed Oncolytic Virus BT-001 Shows Positive Local, Abscopal, and Sustained Antitumoral Activity in Advanced Refractory Tumors

On October 20, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class antibodies for cancer immunotherapy, reported a poster at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting on updated clinical results and positive antitumoral activity of BT-001 in patients with advanced refractory tumors.

The data show that intra-tumoral (IT) BT-001 injection in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) intravenous (IV) anti-PD-1 therapy KEYTRUDA (pembrolizumab[1]), was well tolerated and showed positive local, abscopal and sustained antitumoral activity in injected and non-injected lesions.

Translational analyses reveal increased T cell chemoattractants in the blood and infiltration of activated CD8+ T cells and macrophages in tumors after treatment with BT-001 in combination with pembrolizumab. Significant tumor shrinkage (≥30% decrease in longest diameter) was observed in five of 16 injected lesions (in three patients with melanoma and one patient with sarcoma). Four patients had tumor shrinkage of non-injected lesions.

Long-lasting partial responses (PRs) were observed in a patient with melanoma resistant to anti-PD-1/anti-CTLA-4 combination therapy and in a heavily pre-treated, PD-L1 negative leiomyosarcoma patient.

These immune-mediated tumor shrinkages are consistent with the mechanistic hypothesis that BT-001, in combination with pembrolizumab, turns "cold" tumors into immunologically active ones. The overall data support further development of BT-001 across a range of solid tumors to improve responses to cancer immunotherapies.

Prof. Celeste Lebbé, Dermatologist and Venereologist, Head of Dermatology Department at Hospital Saint-Louis, Paris, commented: "Many cancer patients fail to respond to existing treatments, emphasizing the urgent need for new approaches. BT-001 represents a promising new class of immunotherapy, capable of inducing a potent local immune response through the expression of GM-CSF and an anti-CTLA-4 antibody. These clinical data provide compelling proof of concept, highlighting the relevance of this oncolytic virus in transforming cold tumors into immunologically active ones. Whether administered alone or in combination with pembrolizumab, BT-001 offers the potential to expand treatment options with a favorable safety profile across multiple tumor types."

Dr. Alessandro Riva, Chairman and CEO of Transgene, said: "We are pleased to jointly present these clinical data on BT-001 at ESMO (Free ESMO Whitepaper) 2025, demonstrating encouraging antitumor activity in patients with solid, refractory solid tumors. These updated results confirm BT-001’s mechanism of action as a single agent administered via intra-tumoral injection and show early signs of clinical benefit, including lesion shrinkage and stable disease. With a favorable safety profile – both alone and in combination with pembrolizumab – BT-001 could represent an effective option to enhance responses to immune checkpoint inhibitors (ICI) in patients with limited treatment alternatives. Together with our partner BioInvent, we will continue to explore its safety and efficacy and share further data as it becomes available."

Andres McAllister, MD, PhD, Chief Medical Officer at BioInvent, added: "By combining BT-001 with pembrolizumab, we are building upon the promising data generated by BT-001 as a single agent. Targeting the PD-1/PD-L1 pathway in addition to BT-001’s mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcome. We are pleased to pursue clinical development opportunities with clinicians and further demonstrate the potential of this novel oncolytic virus."

Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to elicit a strong and effective anti-tumoral response in solid tumors.

The poster titled: "Updated clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered in combination with pembrolizumab in patients with advanced solid tumors.", can be accessed at the websites for the ESMO (Free ESMO Whitepaper) conference, Transgene and BioInvent.

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(Press release, Transgene, OCT 20, 2025, https://www.bioinvent.com/en/press/transgene-and-bioinvents-armed-oncolytic-virus-bt-001-shows-positive-local-abscopal-and [SID1234656826])

FDA Grants Fast Track Designation to TAC-001

On October 20, 2025 Tallac Therapeutics reported that the U.S. Food and Drug Administration has granted Fast Track designation to TAC-001 for the treatment of previously treated, locally advanced unresectable or metastatic cholangiocarcinoma.

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Cholangiocarcinoma (CCA) is an aggressive malignancy of the biliary tract with a poor overall prognosis and limited treatment options. The majority (~70%) of patients are diagnosed late at advanced stages and have a 5-year survival rate of less than 10%. Current treatment options, particularly for patients who relapsed after prior systemic treatment, are limited. The designation highlights TAC-001’s potential to address this urgent medical need.

Building on encouraging safety and efficacy Ph1 data in solid tumors, the Fast Track designations will greatly support the clinical development strategy to advance TAC-001, a next-generation antibody-drug conjugate (ADC) designed to safely and efficiently engage both the innate and adaptive anti-tumor immune response.

(Press release, Tallac Therapeutics, OCT 20, 2025, View Source [SID1234656825])