FDA Approvals, News & Updates

On May 6, 2020, the FDA accelerated the approval of oral capmatinib (Tabrecta; Novartis), a kinase inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC). Capmatinib is the first agent approved by the FDA for the treatment of metastatic NSCLC associated with mutations that lead to mesenchymal-epithelial transition (MET) exon 14 skipping, as determined by an FDA-approved test. The FDA granted capmatinib breakthrough therapy and orphan drug designations.

On April 17, 2020, the FDA approved pemigatinib (Pemazyre; Incyte), an oral kinase inhibitor, as the first treatment for adults (aged ≥18 years) with previously treated, locally advanced or metastatic cholangiocarcinoma that is associated with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangements, as detected by an FDA-approved test. This is the first targeted therapy approved for patients with advanced cholangiocarcinoma. Until now, the standard of therapy for this patient population has been chemotherapy combinations.

On April 15, 2020, the FDA approved mitomycin gel (Jelmyto; UroGen Pharma), an alkylating drug as the first treatment for patients with low-grade upper-tract urothelial cancer. Mitomycin is a combination of chemotherapy and a sterile hydrogel that stops the transcription of DNA into RNA and halts the synthesis of protein, thereby blocking the ability of cancer cells to multiply. The FDA granted mitomycin gel priority review, breakthrough therapy, fast track, and orphan drug designations.

On May 29, 2020, the FDA approved ramucirumab (Cyramza; Eli Lilly) in combination with erlotinib (Tarceva) for first-line treatment of patients with metastatic non–small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Ramucirumab was previously approved for several types of cancer, including, in combination with docetaxel, for metastatic NSCLC, after platinum-based chemotherapy.

On May 26, 2020, the FDA approved nivolumab (Opdivo; BMS) and ipilimumab (Yervoy; BMS) plus chemotherapy as first-line treatment of recurrent or metastatic squamous or nonsquamous non–small-cell lung cancer (NSCLC), regardless of PD-L1 expression, and with no EGFR or ALK aberrations. On May 15, the FDA approved nivolumab plus ipilimumab as first-line treatment of metastatic NSCLC with PD-L1 ≥1% expression.

On May 29, 2020, the FDA approved the immunotherapy atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, in combination with bevacizumab (Avastin; Genentech), a vascular endothelial growth factor inhibitor, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received systemic therapy. This is the first immunotherapy regimen approved by the FDA for this type of HCC.

On May 19, 2020, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), a PARP inhibitor, for the treatment of men with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic HRR mutation, as determined by an FDA-approved test, whose disease progressed after enzalutamide (Xtandi) or abiraterone acetate (Zytiga) therapy. Olaparib is the first FDA-approved PARP inhibitor for prostate cancer.

On May 18, 2020, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for the first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) whose tumor has high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), and no EGFR or ALK genomic aberrations, as determined by an FDA-approved test.

On May 15, 2020, the FDA approved a new indication for the first immunotherapy combination with the PD-1 inhibitor nivolumab (Opdivo; BMS) and the CTLA-4 inhibitor ipilimumab (Yervoy; BMS) as first-line treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and PD-L1 expression of ≥1%, as determined by an FDA-approved test, but without EGFR or ALK genomic alterations.

On May 1, 2020, the FDA approved a new formulation of daratumumab (Darzalex; Janssen Biotech) and hyaluronidase-fihj (Faspro; Janssen Biotech) for the treatment of adults with newly diagnosed or with relapsed or refractory multiple myeloma. This new formulation allows for the subcutaneous administration of daratumumab as an alternative to its intravenous (IV) administration. The new formulation is approved for the indications previously approved for IV daratumumab.