Entries by Business Wire

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Bristol Myers Squibb Receives European Commission Approval for Abecma

The European Commission granted Conditional Marketing Authorization for Bristol Myers Squibb’s Abecma (idecabtagene vicleucel; ide-cel) – a first-in-class B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy – for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

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Opdivo in Combination with Cabometyx Shows Sustained Survival and Response Rate Benefits as First-Line Treatment for Patients with Advanced RCC

Bristol Myers Squibb and Exelixis announced results from new analyses from the pivotal Phase 3 CheckMate -9ER trial, demonstrating clinically meaningful, sustained efficacy benefits as well as quality of life improvements with the combination of Opdivo (nivolumab) and Cabometyx (cabozantinib) compared to sunitinib in the first-line treatment of advanced renal cell carcinoma (RCC).

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FDA Approves Ocrevus Shorter 2-Hour Infusion for Relapsing and Primary Progressive MS

The U.S. Food and Drug Administration approved a shorter two-hour infusion time for Roche Group member Genentech’s Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions.

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U.S. FDA Grants Priority Review for Pfizer’s 20vPnC

The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.

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New Data Reinforce Long-Term Benefit of Venclexta-Based Combination for Relapsed or Refractory CLL

Roche Group member Genentech announced that new data from the pivotal Phase III MURANO and CLL14 studies support the efficacy of fixed-duration, chemotherapy-free Venclexta (venetoclax)-based combinations in certain people with chronic lymphocytic leukemia (CLL) and provide more evidence on the potential value of minimal residual disease.

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FDA Approves Keytruda for Triple‑Negative Breast Cancer

The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 as determined by an FDA-approved test.