FDA Approvals, News & Updates

On February 5, 2021, the FDA approved lisocabtagene maraleucel (Breyanzi; Bristol Myers Squibb), a new chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after ≥2 lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma. Read Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 Article ›

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 ›

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