FDA Approvals, News & Updates
On January 22, 2021, the FDA approved the combination of nivolumab (Opdivo; Bristol Myers Squibb), an immune checkpoint inhibitor, and cabozantinib (Cabometyx; Exelixis), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal-cell carcinoma. Read More ›
On January 14, 2021, the FDA approved crizotinib (Xalkori; Pfizer), an oral tyrosine kinase inhibitor, for the treatment of pediatric patients aged ≥1 years and young adults with relapsed or refractory systemic ALK-positive anaplastic large-cell lymphoma (ALCL). The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory systemic ALK-positive ALCL. Read More ›
On December 18, 2020, the FDA approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (Orgovyx; Myovant Sciences), for the treatment of adult patients with advanced prostate cancer. As an GnRH receptor, relugolix reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Read More ›
On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels. Read More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›
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 More ›