The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues.
FDA has approved Zusduri as the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
FDA has approved tafasitamab-cxix (Monjuvi, Incyte Corporation) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma.
FDA has approved a new tablet formulation of Brukinsa (zanubrutinib) for all five approved indications. Brukinsa remains the leader in new chronic lymphocytic leukemia patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader.
FDA has approved Ibtrozi (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Stand Up To Cancer and SandboxAQ announced a collaboration that brings SandboxAQ’s Large Quantitative Models to SU2C-funded cancer research projects.
FDA approved the oral androgen receptor inhibitor Nubeqa (darolutamide) for the treatment of adult patients with metastatic castration-sensitive prostate cancer, which is also known as metastatic hormone-sensitive prostate cancer.
Clairity Inc. received FDA De Novo authorization for CLAIRITY BREAST, a novel, image-based prognostic platform designed to predict five-year breast cancer risk from a routine screening mammogram. With this authorization, Clairity is planning to launch among leading health systems through 2025—propelling a new era of precision medicine in breast cancer.
The European Commission June 3 approved Adcetris (brentuximab vedotin) in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine and dexamethasone—a chemotherapy regimen—in adult patients with newly diagnosed stage 2b with risk factors, stage 3, and stage 4 Hodgkin lymphoma. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use on April 25.
The National Medical Products Administration in China approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer.
