FDA Approvals, News & Updates

On July 24, 2020, the FDA accelerated the approval of brexucabtagene autoleucel (Tecartus; Kite Pharma), a CAR T-cell therapy, for the treatment of adults with mantle-cell lymphoma (MCL) whose disease has not responded to or has relapsed after other therapies. Brexucabtagene autoleucel is the first gene therapy FDA-approved specifically for the treatment of patients with MCL, a rare type of B-cell non-Hodgkin’s lymphoma.

On July 31, 2020, the FDA accelerated the approval of tafasitamab-cxix (Monjuvi; Incyte/MorphoSys US), a CD19-directed cytolytic antibody, in combination with lenalidomide (Revlimid) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, who are not eligible for autologous stem-cell transplant.

On August 5, 2020, the FDA accelerated the approval of belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with relapsed or refractory multiple myeloma who have received ≥4 previous therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

On September 4, 2020, the FDA accelerated the approval of pralsetinib (Gavreto; Blueprint Medicines/Genentech), an oral RET inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and RET-activating fusions, as detected by an FDA-approved test.

On June 10, 2020, the FDA accelerated the approval of a new indication for nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous-cell carcinoma after fluoropyrimidine-based and platinum-based chemotherapy. Nivolumab has been previously approved for many indications, but this is its first indication for esophageal cancer.

On June 15, 2020, the FDA accelerated the approval of lurbinectedin (Zepzelca; Jazz Pharma/Pharma Mar), an intravenous alkylating drug, for the treatment of adults with metastatic small-cell lung cancer that has progressed during or after platinum-based chemotherapy. The FDA granted lurbinectedin an orphan drug designation for this indication.

On May 8, 2020, the FDA accelerated the approval of a new kinase inhibitor, selpercatinib (Retevmo; Loxo Oncology) capsules, for the treatment of 3 types of cancer—metastatic non–small-cell lung cancer (NSCLC), metastatic medullary thyroid cancer, and other types of thyroid cancer—that are associated with RET gene mutations or fusions, as determined by an FDA-approved test. Selpercatinib is the first therapy approved specifically for the treatment of patients with cancer that is linked to RET mutations or fusions. The FDA granted selpercatinib breakthrough therapy and orphan drug designations.

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.