FDA News & Updates
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. Read More ›
This section provides a brief overview of new cancer drugs or new indications approved by the FDA between March 2 and March 27, 2020. Read More ›
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. Read More ›
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 metastatic NSCLC with mutations that lead to MET exon 14 skipping, as determined by the FoundationOne CDx assay, which is approved as a companion diagnostic for capmatinib. Read More ›
On May 8, 2020, the FDA approved selpercatinib (Retevmo; Loxo Oncology) capsules for the treatment of 3 types of cancer associated with RET gene mutations or fusions, including (1) metastatic non–small-cell lung cancer, (2) metastatic medullary thyroid cancer, and (3) other types of thyroid cancers. Selpercatinib is the first therapy approved for patients with cancer that is linked to RET mutations. Read More ›
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. Read More ›
On April 29, 2020, the FDA accelerated the approval of the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula; GlaxoSmithKline) as the first and only drug approved for first-line maintenance therapy of all patients with advanced ovarian cancer—including epithelial ovarian, fallopian tube, or primary peritoneal cancer—who have had a complete or partial response to first-line platinum-based chemotherapy. Read More ›
On April 28, 2020, the FDA accelerated the approval of a new dosing regimen—400 mg every 6 weeks—for pembrolizumab (Keytruda; Merck) for all the 15 indications currently approved by the FDA for adults using this PD-1 inhibitor. The new dosing regimen is a new option in addition to the current dosing regimen of 200 mg every 3 weeks. This is great news for patients, as well as for oncology providers. Read More ›
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 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 ›