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12 FDA oncology stories you may have missed
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In August, the FDA issued several approvals and review designations across the field of oncology. HemOnc Today has compiled a list of the past month’s approvals, updates and submissions.
FDA approves Opdivo for metastatic small cell lung cancer
The FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with metastatic small cell lung cancer who progressed after platinum-based chemotherapy and at least one other line of therapy. READ MORE.
FDA approves Lenvima for unresectable liver cancer
The FDA approved lenvatinib (Lenvima, Eisai)— a multiple receptor tyrosine kinase inhibitor —for the first-line treatment of patients with unresectable hepatocellular carcinoma. READ MORE.
FDA grants breakthrough device designation to cancer-detecting blood test
The FDA granted the PapGene liquid biopsy test breakthrough device designation for the detection of cancer among people aged older than 65 years. READ MORE.
FDA grants fast track designation to AVB-S6-500 for ovarian cancer
The FDA granted AVB-S6-500 (Aravive Biologics), an inhibitor of the GAS6-AXL signaling pathway, fast track designation for the treatment of women with platinum-resistant recurrent ovarian cancer. READ MORE.
FDA approves cobas EGFR Mutation Test for use with Iressa in lung cancer
The FDA expanded the approval of a liquid/tissue biopsy test for EGFR mutations as a companion diagnostic with gefitinib (Iressa, AstraZeneca) in the first-line treatment of patients with non-small cell lung cancer. READ MORE.
FDA approves Azedra for rare adrenal gland tumors
The FDA approved iobenguane I 131 (Azedra, Progenics Pharmaceuticals) for adults and children with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require anticancer therapy. READ MORE.
FDA grants Braftovi-Mektovi plus Erbitux breakthrough therapy designation for colorectal cancer
The FDA granted breakthrough therapy designation to the combination of encorafenib (Braftovi, Array BioPharma), binimetinib (Mektovi, Array BioPharma) and cetuximab (Erbitux, Eli Lilly) for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer following the failure of one or two prior lines of therapy. READ MORE.
FDA approves Tibsovo for IDH1 -mutated acute myeloid leukemia
The FDA approved ivosidenib (Tibsovo, Agios Pharmaceuticals) — an oral targeted inhibitor of the IDH1 enzyme — for the treatment of adults with relapsed or refractory AML who harbor IDH1 mutations detected by an FDA-approved test. READ MORE.
FDA updates prescribing information for Keytruda, Tecentriq
The FDA updated the prescribing information for pembrolizumab (Keytruda, Merck) and atezolizumab (Tecentriq, Genentech) to require use of an FDA-approved diagnostic test to determine PD-L1 levels among patients with locally advanced or metastatic urothelial cancer who are cisplatin ineligible. READ MORE.
FDA grants priority review to Empliciti combination for multiple myeloma
The FDA granted priority review designation to elotuzumab (Empliciti; Bristol-Myers Squibb, AbbVie) in combination with pomalidomide (Pomalyst, Celgene) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma, who have received at least two prior therapies, including lenalidomide (Revlimid, Celgene) and a proteasome inhibitor. READ MORE.
FDA grants regular approval to Keytruda-chemotherapy combination for nonsquamous non-small cell lung cancer
The FDA granted regular approval to pembrolizumab in combination with pemetrexed and platinum-based chemotherapy as first-line treatment of patients with metastatic nonsquamous NSCLC. The approval applies to patients who do not harbor EGFR or ALK genomic tumor aberrations. READ MORE.
FDA grants orphan drug designation to ASLAN003 for acute myeloid leukemia
The FDA granted orphan drug designation to ASLAN003 (ASLAN Pharmaceuticals), an oral inhibitor of human dihydroorotate dehydrogenase, for the treatment of AML. READ MORE.