FDA Approvals, News & Updates

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. Read Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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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