FDA Approvals, News & Updates

On March 10, 2020, the FDA accelerated the approval of the immunotherapy combination of nivolumab (Opdivo; Bristol-Myers Squibb) plus ipilimumab (Yervoy; Bristol-Myers Squibb) for patients with hepatocellular carcinoma (HCC) who have previously received sorafenib. Nivolumab and ipilimumab have been previously approved by the FDA for several indications. This new indication was previously granted a breakthrough therapy designation.

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On March 2, 2020, the FDA approved isatuximab-irfc (Sarclisa; Sanofi- Aventis), a CD38-directed cytolytic antibody, for the treatment of adults with multiple myeloma, for use in combination with pomalidomide (Pomalyst) and dexamethasone, in patients who had received at least 2 therapies that include lenalidomide (Revlimid) and a proteasome inhibitor. The FDA granted isatuximab an orphan drug designation.

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Mitomycin gel (Jelmyto), an alkylating drug, is the first and only FDA-approved treatment for patients with low-grade upper-tract urothelial cancer (UTUC), a rare cancer that affects the lining of the urinary system, and offers a nonsurgical treatment alternative for patients with this rare disease. Although the majority of urothelial cancers occur in the bladder, UTUC is part of a group of urothelial cancers that arise in the lining of the kidney or the ureter. Read More ›

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 More ›

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 ›