FDA Approvals, News & Updates

On January 23, 2020, the FDA approved tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of adults and pediatric patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. The FDA granted tazemetostat accelerated approval and designated it as an orphan drug. Read Article ›

On January 9, 2020, the FDA approved avapritinib (Ayvakit; Blueprint Medicines), a kinase inhibitor, for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. The FDA designated avapritinib as a breakthrough therapy and an orphan drug. Avapritinib was also granted Fast Track designation. Read Article ›

On January 8, 2020, the FDA approved pembrolizumab (Keytruda; Merck) for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Keytruda has received previous FDA approval as a single agent or in combination with other agents for the treatment of many types of cancers. Read Article ›

On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020. Read Article ›

On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection. Read Article ›

The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases. Read Article ›

On December 3, 2019, the FDA approved atezolizumab (Tecentriq; Genentech), in combination with paclitaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults with metastatic nonsquamous non–small-cell lung cancer (NSCLC) that does not harbor EGFR or ALK genomic mutations. Read Article ›

On December 16, 2019, the FDA approved a new indication for enzalutamide (Xtandi; Pfizer, Astellas) for the treatment of patients with metastatic castration-sensitive prostate cancer. Enzalutamide was previously approved for the treatment of patients with nonmetastatic and metastatic castration-resistant prostate cancer. Read Article ›

On December 27, 2019, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetics) as a companion diagnostic to select patients with pancreatic cancer who are candidates for treatment with olaparib based on the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. Read Article ›

The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer. Read Article ›

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