FDA Approvals, News & Updates

On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.

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.

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.

On January 8, 2020, the American Cancer Society published details of their annual cancer statistics report, including the most recent data on population‐based findings for cancer incidence through 2016 and for mortality through 2017 (CA Cancer J Clin. 2020;70:7-30). The report revealed encouraging news as well as some sobering trends.

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.

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.

On October 23, 2019, the FDA approved a new indication for the PARP inhibitor niraparib (Zejula; Tesaro) for the treatment of patients with homologous recombination deficiency repair (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer, after receiving ≥3 chemotherapy regimens.

On November 21, 2019, the FDA accelerated the approval of acalabrutinib (Calquence; AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma. This drug was approved 4 months earlier than the FDA PDUFA date.

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.

On November 5, 2019, the FDA approved pegfilgrastim-bmez (Ziextenzo; Sandoz) as a third biosimilar to Neulasta (pegfilgrastim), a granulocyte colony-stimulating factor. The previous 2 biosimilars to Neulasta were approved in 2018.