FDA Approvals, News & Updates

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. Read Article ›

On August 5, 2020, the FDA accelerated the approval of belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline), a B-cell maturation antigen–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. Read Article ›

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. Read Article ›

On October 23, 2020, the FDA approved FoundationOne CDx to be used as a companion diagnostic for larotrectinib (Vitrakvi; Bayer), a drug currently approved by the FDA for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Read Article ›

On October 16, 2020, the FDA granted full approval to venetoclax (Venclexta; AbbVie and Genentech) in combination with azacitidine, decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia (AML) in adults aged ≥75 years or who have comorbidities precluding intensive induction chemotherapy. Read Article ›

On July 24, 2020, the FDA approved brexucabtagene autoleucel (Tecartus; Kite Pharma), a chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients diagnosed with mantle-cell lymphoma (MCL) who have not responded to, or who have relapsed following, other kinds of treatment. Read Article ›

On July 7, 2020, the FDA approved decitabine plus cedazuridine (Inqovi; Astex Pharmaceuticals) tablets for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes, including patients with chronic myelomonocytic leukemia. Inqovi is an orally administered fixed-dose combination of the hypomethylating agent decitabine plus the cytidine deaminase inhibitor cedazuridine. Read Article ›

On June 30, 2020, the FDA approved avelumab (Bavencio; Pfizer) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval was based on results of the randomized, multicenter, open-label, phase 3 JAVELIN Bladder clinical trial. This study enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized to avelumab given intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.

Read Article ›

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. Read Article ›

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. Read Article ›

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