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Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy

On June 26, 2026 Astrazeneca and Daiichi Sankyo reported that Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

In TROPION-Breast02, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) versus investigator’s choice of chemotherapy (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291). Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR=0.57; 95% CI: 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway was also associated with more robust treatment responses compared to chemotherapy, with an objective response rate (ORR) of 62.5% versus 29.3% for those treated with chemotherapy.

"Triple negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU."

"As one of the hardest cancers to treat, today only 15% of patients with metastatic triple negative breast cancer survive beyond five years," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU."

The safety profile of Datroway (6 mg/kg) was evaluated in 319 patients with TNBC who received Datroway in TROPION-Breast02. The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased alanine aminotransferase, increased aspartate aminotransferase, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium and increased blood alkaline phosphatase. Serious adverse reactions occurred in 17% of patients who received Datroway. Serious adverse reactions in more than 1% of patients who received Datroway included pneumonia, vomiting, COVID-19 and anemia. One patient fatality was attributed to interstitial lung disease/pneumonitis.

Datroway was approved in the U.S. in May 2026 for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis.

About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are OS and PFS as assessed by BICR. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.1,2 In Europe, there are an estimated 83,000 diagnoses of TNBC each year.1,3 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.4,5,6 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.4,7,8

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.4 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.4 For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting.9,10 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard first-line treatment.11

TROP2 is a protein broadly expressed in several solid tumors, including TNBC.12 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.13,14

About Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway (6 mg/kg) is approved in Brazil, Russia and the U.S. for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.

Datroway (6 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

Datroway (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, AstraZeneca, JUN 26, 2026, View Source [SID1234668976])

PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen™ (ropeginterferon alfa-2b-njft) for Polycythemia Vera

On June 26, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen is expected to become commercially available in the U.S. in the coming weeks.

"The U.S. approval of the BESREMi Pen is a significant milestone both for our company, as well as the patients we serve," said Samuel Lin, Head of Global Operations, PharmaEssentia. "With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care."

"I’m very excited to see the FDA approval of the BESREMi Pen as a new option for patients," said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. "Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence."

(Press release, PharmaEssentia, JUN 26, 2026, View Source [SID1234668975])

FibroBiologics Announces up to $9.0 Million Private Placement Priced At-the-Market Under Nasdaq Rules

On June 26, 2026 FibroBiologics, Inc. (NASDAQ: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 4,081,633 shares of common stock (or pre-funded warrants in lieu thereof), series A warrants to purchase up to 4,081,633 shares of common stock and short-term series B warrants to purchase up to 4,081,633 shares of common stock at a purchase price of $0.735 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. The series A warrants and the short-term series B warrants will have an exercise price of $0.735 per share and will be exercisable on or after the effective date of stockholder approval (the "Stockholder Approval Date") of the issuance of the shares of common stock upon exercise of the warrants (the "Stockholder Approval"). The series A warrants will expire five years from the later of the Stockholder Approval Date and the effective date (the "Effective Date") of the resale registration statement registering the shares of common stock issuable upon exercise of the series warrants, and the short-term series B warrants will expire eighteen months from the later of the Stockholder Approval Date and the Effective Date. The private placement is expected to close on or about June 29, 2026, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $3.0 million, before deducting placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A and series B warrants, if fully exercised on a cash basis, will be approximately $6.0 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, the Company has agreed to file a resale registration statement covering the securities described above.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, FibroBiologics, JUN 26, 2026, View Source [SID1234668973])

Anixa Biosciences Reports Positive Data from Completed Breast Cancer Vaccine Phase 1 Trial and Positive Survival Observations from Ongoing CAR-T Phase 1 Trial at New York Academy of Sciences’ Frontiers in Cancer Immunotherapy Symposium

On June 26, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its two clinical-stage immunotherapy programs were presented at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy symposium this week.

The presentations highlighted Anixa’s breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which recently completed a Phase 1 clinical trial in which all major primary endpoints were met and protocol-defined immune responses were generated in 74% of participants, and Anixa’s ovarian cancer CAR-T therapy, liraltagene autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center.

Both presentations may be accessed on the Events page of Anixa Biosciences’ website: View Source

"Presenting both of our clinical-stage immunotherapy programs at this symposium was an important opportunity to highlight the progress of our pipeline and the strength of the collaborations supporting these programs," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Our breast cancer vaccine and ovarian cancer CAR-T therapy are being advanced with leading clinical and scientific institutions, and we believe these presentations underscore the potential of Anixa’s approach to treating and preventing cancer."

The Company’s breast cancer vaccine presentation, titled "Phase I Trial of an Alpha-Lactalbumin (aLA) Vaccine for Breast Cancer," was given by Dr. Emily Esakov Rhoades, FDA/IND Trial Program Manager, Cleveland Clinic Cancer Institute. The presentation reported final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants.

The Company’s lira-cel presentation, titled "A Phase I Clinical Trial of an Infusion of Autologous T cells Genetically Engineered with a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients with Recurrent Ovarian Cancer," was given by Dr. Pamela D. Garzone, Chief Development Officer of Anixa Biosciences. The presentation reported the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel, including survival observations of multiple patients living over one year past treatment.

About Anixa’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine represents a novel approach to the prevention and treatment of breast cancer. The vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is highly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian and testis cells, tumor vasculature, and certain cancer cells, but not in other healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who are platinum resistant and have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, JUN 26, 2026, View Source [SID1234668972])

Lilly’s Jaypirca (pirtobrutinib) recommended by CHMP for approval in the European Union for adults with chronic lymphocytic leukemia (CLL) across all lines of therapy

On June 26, 2026 Eli Lilly and Company (NYSE: LLY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jaypirca (pirtobrutinib), a non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with chronic lymphocytic leukemia (CLL) across all lines of therapy and regardless of prior BTK inhibitor treatment. Following this positive opinion, the application is now referred to the European Commission for final action. The European Commission’s decision is expected in the next one to two months.

"Results from BRUIN CLL-313 and BRUIN CLL-314 provide compelling evidence that pirtobrutinib can make a meaningful difference for people living with CLL across multiple lines of therapy," said Paolo Ghia, M.D., professor, medical oncology, Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy. "The strong efficacy and tolerability demonstrated in these trials underscores the clinical value pirtobrutinib may offer patients. This positive opinion from the CHMP is an exciting and significant milestone, bringing us closer to a future where pirtobrutinib is an option for more people with CLL across the European Union."

Results from BRUIN CLL-313 and BRUIN CLL-314 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025 and published in The Journal of Clinical Oncology.

"Based on the strong results from the BRUIN CLL-313 and CLL-314 studies, we believe Jaypirca has the potential to serve as a meaningful new option for newly diagnosed patients and those who have not yet received a BTK inhibitor," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "Thanks to the impact of contemporary CLL treatments, many patients may receive fewer lines of therapy over their lifetime, making treatment choices in earlier lines profoundly important. This CHMP opinion represents a step toward an important global approval for Jaypirca in this indication and reflects our ambition to make Jaypirca available to every CLL patient who may benefit, at any line of therapy. Today, we are on the brink of making that a reality across the European Union as we await the European Commission’s final decision."

Lilly has also submitted these results to the U.S. Food and Drug Administration (FDA) for approval for adult patients with CLL, with a decision expected in the second half of 2026.

About BRUIN CLL-313
BRUIN CLL-313 is a Phase 3, global, randomized, open-label study of pirtobrutinib versus chemoimmunotherapy (BR) in people with CLL/SLL without 17p deletions who have not been previously treated. The trial enrolled 282 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or BR per labeled doses. BR is a chemoimmunotherapy regimen used in the treatment of CLL. The primary endpoint is PFS as assessed by blinded IRC. Secondary endpoints include investigator and IRC assessed ORR, duration of response (DoR), and PFS, OS, time to next treatment (TTNT), safety and tolerability and patient-reported outcomes (PRO).

About BRUIN CLL-314
BRUIN CLL-314 is a Phase 3, randomized, open-label study of Jaypirca (pirtobrutinib) versus Imbruvica (ibrutinib) in patients with CLL/SLL who were either treatment-naïve, or who were previously treated and were BTK inhibitor-naïve. The trial enrolled 662 patients who were randomized 1:1 to receive pirtobrutinib (200 mg orally, once daily) or ibrutinib (420 mg orally, once daily). The primary endpoint is ORR as assessed by blinded IRC. Secondary endpoints include investigator and IRC-assessed PFS, duration of response (DoR) and event-free survival (EFS), and time to next treatment (TTNT), OS, safety and tolerability, and patient-reported outcomes (PRO).

About Jaypirca (pirtobrutinib)
Jaypirca (pirtobrutinib, formerly known as LOXO-305) (pronounced jay-pihr-kaa) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent inhibitor of the enzyme BTK.1 BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).2,3 Jaypirca is a U.S. FDA-approved oral prescription medicine, 100 mg or 50 mg tablets taken as a once-daily 200 mg dose with or without food until disease progression or unacceptable toxicity.

About Chronic Lymphocytic Leukemia (CLL)
CLL is a form of slow-growing non-Hodgkin lymphoma that develops from white blood cells known as lymphocytes.4,5 CLL is one of the most common types of leukemia in adults.6 There are roughly 100,000 new cases of CLL globally each year, and the overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year.6,7 In CLL, the cancer cells are present in the blood.6

INDICATIONS FOR JAYPIRCA (pirtobrutinib) (in the United States)

Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. 
Adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in a confirmatory trial.
IMPORTANT SAFETY INFORMATION FOR JAYPIRCA (pirtobrutinib)

Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. Across clinical trials, Grade ≥3 infections occurred (25%), most commonly pneumonia (20%); fatal infections (5%), sepsis (6%), and febrile neutropenia (3.8%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor for signs and symptoms, evaluate, and treat. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Across clinical trials, major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred (2.6%), including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred (16%). Major hemorrhage occurred when taking Jaypirca with (2.0%) and without (0.6%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider withholding Jaypirca 3-7 days pre- and post-surgery based on surgery type and bleeding risk.

Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. Across clinical trials, Grade 3 or 4 cytopenias, including decreased neutrophils (27%), decreased platelets (13%), and decreased hemoglobin (11%), developed. Grade 4 decreased neutrophils (15%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients taking Jaypirca. Across clinical trials, atrial fibrillation or flutter were reported in 3.4% of Jaypirca treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.6%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.4%). Cardiac risk factors such as hypertension or previous arrhythmias may increase risk. Monitor and manage signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea). Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Across clinical trials, second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients, most frequently non-melanoma skin cancer (4.4%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Hepatotoxicity, Including Drug-Induced Liver Injury (DILI): Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of DILI, has occurred in patients treated with BTK inhibitors, including Jaypirca. Evaluate bilirubin and transaminases at baseline and throughout Jaypirca treatment. For patients who develop abnormal liver tests after Jaypirca, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold Jaypirca. If DILI is confirmed, discontinue Jaypirca.

Embryo-Fetal Toxicity: Jaypirca can cause fetal harm. Administration of pirtobrutinib to pregnant rats caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients Who Received Jaypirca
The most common (≥30%) ARs in the pooled safety population of patients with hematologic malignancies (n=704) were decreased neutrophil count (54%), decreased hemoglobin (43%), decreased leukocytes (32%), fatigue (31%), decreased platelets (31%), decreased lymphocyte count (31%), calcium decreased (30%).

Mantle Cell Lymphoma

Serious ARs occurred in 38% of patients, with pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%) occurring in ≥2% of patients. Fatal ARs within 28 days of last dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. Permanent discontinuation in >1% of patients included pneumonia.

Most common ARs (≥15%) and Select Laboratory Abnormalities (≥10%) (all Grades %; Grade 3-4 %): hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), fatigue (29; 1.6), musculoskeletal pain (27; 3.9), calcium decreased (19; 1.6), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), AST increased (17; 1.6), pneumonia (16; 14), bruising (16; -), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), ALT increased (11; 1.6), potassium increased (11; 0.8), alkaline phosphatase increased (11; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma from Single-Arm and Randomized Controlled Clinical Trials

Serious ARs occurred in 47-56% of patients across clinical trials. Serious ARs in ≥5% of patients in the single-arm trial were pneumonia (18%), COVID-19 (9%), sepsis (7%), febrile neutropenia (7%). Serious ARs in ≥3% of patients in the randomized controlled trial were pneumonia (21%), COVID-19 (5%), sepsis (3.4%). Fatal ARs within 28-30 days of last Jaypirca dose occurred in 8-11% of patients, most commonly due to infections (7-10%), including sepsis (5%), COVID-19 (2.7-5%), and pneumonia (3.4%).

Dose Modifications and Discontinuations Due to ARs: Dose reductions in 3.6-10%, treatment interruption in 42-51%, and permanent discontinuation of Jaypirca in 9-17% of patients. Permanent discontinuation in >1% of patients included second primary malignancy, pneumonia, COVID-19, neutropenia, sepsis, anemia, and cardiac arrythmias.

Most common ARs and Select Laboratory Abnormalities (≥20%) (all Grades %, Grade 3-4 %)–in a randomized controlled trial: neutrophil count decreased (54; 26), hemoglobin decreased (45; 10), platelet count decreased (37; 17), pneumonia (28; 16), ALT increased (25; 1.8), creatinine increased (25; -), calcium decreased (23; 0.9), sodium decreased (22; 0.9), bilirubin increased (21; 0.9), upper respiratory tract infections (21; 0.9); in a single-arm trial: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), platelet count decreased (30; 15), sodium decreased (30; -), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), dyspnea (22; 2.7), hemorrhage (22; 2.7), lipase increased (21; 7), alkaline phosphatase increased (21; -), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).

Drug Interactions

Strong CYP3A Inhibitors: Concomitant use increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid using strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dose according to approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid using Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dose according to approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Use with Jaypirca increased their plasma concentrations, which may increase risk of ARs related to these substrates for drugs sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Specific Populations

Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca. Presence of pirtobrutinib in human milk is unknown. Advise women to use effective contraception and to not breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Because severe renal impairment increases pirtobrutinib exposure, reduce Jaypirca dose in these patients according to approved labeling.

(Press release, Eli Lilly, JUN 26, 2026, View Source [SID1234668971])