The FDA has accepted for priority review the supplemental new drug application for belzutifan to treat adults with advanced renal cell carcinoma who previously received immune checkpoint and anti-angiogenic therapies.
Ivosidenib produced an objective response rate of 83.3% in a phase 1 trial of patients with IDH1-mutated, relapsed or refractory MDS.
Elrexfio is expected to be available in the coming weeks.
The FDA has approved Akeega (niraparib and abiraterone acetate) to treat BRCA-mutated metastatic castration-resistant prostate cancer.
The FDA has issued a complete response letter related to the new drug application for avasopasem manganese to treat radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard treatment.
The FDA has granted accelerated approval to Talvey (talquetamab) for the treatment of adults with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy.
The FDA has granted full approval to Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive NSCLC.
Vanflyta is available only through a risk evaluation and mitigation strategy program.
The FDA has approved extending the use of CMV prophylaxis with Prevymis (letermovir) from 100 days to 200 days post-transplant.
The FDA has issued a complete response letter regarding denileukin diftitox for relapsed or refractory cutaneous T-cell lymphoma.
