FDA Approvals, News & Updates
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
On November 21, 2019, the FDA approved acalabrutinib (Calquence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the second approval under Project Orbis, a collaboration between the FDA, the Australian Therapeutic Goods Administration, and Health Canada. Read More ›