Drug Approvals

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

The FDA has approved pembrolizumab (Keytruda) and its subcutaneous version, Keytruda Qlex, for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. The approval is for patients whose tumors test positive for PD-L1 (Combined Positive Score of 1 or higher) and who have already received one or two prior treatment regimens. The decision is

The FDA has given Fast Track designation to pelareorep (Reolysin), an intravenous oncolytic virus therapy, for second-line treatment of patients with KRAS-mutant, microsatellite-stable metastatic colorectal cancer. The therapy is used in combination with standard treatment, bevacizumab plus FOLFIRI. The decision is based on Phase 1 trial data showing strong improvements compared with historical standard care.

The FDA has approved Rybrevant Faspro (amivantamab with hyaluronidase) as a subcutaneous injection for adults with EGFR-mutated non-small cell lung cancer, covering all previous intravenous indications. The subcutaneous version works as well as the IV form, with similar effectiveness and overall survival, but can be given in about 5 minutes instead of 2–5 hours. It also greatly

Elevar Therapeutics has resubmitted its FDA application for rivoceranib plus camrelizumab as a first-line treatment for unresectable liver cancer (HCC). Previous delays were due to manufacturing and inspection issues, not concerns about the drug’s safety or effectiveness. The Phase 3 CARES-310 trial showed the combination significantly outperformed the former standard, sorafenib. Patients lived a median of

The FDA has accepted a Biologics License Application for ivonescimab (AK112), a new bispecific antibody for patients with EGFR-mutated, nonsquamous non-small cell lung cancer that has progressed after third-generation TKI treatment. Phase 3 HARMONi trial data from 438 patients showed that ivonescimab combined with chemotherapy significantly slowed disease progression. Median progression-free survival improved from 4.4

The FDA has approved ziftomenib (Komzifti) for adults with relapsed or refractory acute myeloid leukemia (AML) harboring NPM1 mutations and lacking other effective treatments. This provides a new option for a challenging AML subgroup. Approval was based on the phase 1/2 KOMET-001 trial, which showed a 21.4% complete remission (CR/CRh) rate, with responses lasting a median of five