FDA Approvals, News & Updates
On February 5, 2021, the FDA granted accelerated approval to umbralisib (Ukoniq; TG Therapeutics), a dual inhibitor of PI3Kδ and CK1ε, for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received ≥1 previous anti-CD20–based regimens, and adult patients with relapsed or refractory follicular lymphoma who have received ≥3 previous lines of systemic therapy. Read More ›
On February 3, 2021, the FDA accelerated the approval of tepotinib (Tepmetko; EMD Serono), an oral MET kinase inhibitor, for the treatment of patients with metastatic non–small-cell lung cancer (NSCLC) who harbor MET exon 14 skipping alterations. Read More ›
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 ›