When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
The FDA Oncologic Drugs Advisory Committee voted 12:2 to recommend approval of the drug imetelstat for a myelodysplastic syndrome indication.
FDA has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor CAR T-cell therapy for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
FDA has approved Tevimbra (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor, or EGFR, exon 20 insertion mutations, as detected by an FDA-approved test.
FDA approved Opdivo (nivolumab) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
FDA granted accelerated approval to Brukinsa (zanubrutinib) with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
FDA approved Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), the first FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.
FDA granted the next-generation selective RET inhibitor EP0031/A400 Fast Track designation for the potential treatment of RET-fusion positive non-small cell lung cancer.
FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma.
