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The European Commission has granted conditional marketing approval to Anktiva in combination with BCG for adults with high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Until now, patients in Europe whose cancer did not respond to BCG often had very limited options and frequently needed radical cystectomy, the surgical removal of the bladder. The decision is […]

The U.S. Food and Drug Administration has accepted a New Drug Application for iberdomide, an oral CELMoD, to be used with Darzalex (daratumumab) and dexamethasone for patients with relapsed or refractory multiple myeloma. The combination, known as IberDd, has received Breakthrough Therapy Designation. The application is based on interim results from the Phase 3 EXCALIBER-RRMM

The U.S. Food and Drug Administration has accepted the New Drug Application for Velexbru (tirabrutinib), a BTK inhibitor, to treat relapsed or refractory primary central nervous system lymphoma (PCNSL). PCNSL is a rare and aggressive type of non-Hodgkin lymphoma that affects the brain and central nervous system. The application is based on results from the Phase

The U.S. Food and Drug Administration has approved a simpler once-monthly (every 4 weeks) dosing schedule for Rybrevant Faspro (subcutaneous amivantamab with hyaluronidase) combined with lazertinib as first-line treatment for advanced EGFR-mutated non-small cell lung cancer (NSCLC). Patients can switch to the monthly schedule as early as Week 5, reducing the need for frequent clinic