The Lynx Group

FDA Approvals, News & Updates

On November 13, 2020, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, plus chemotherapy, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in patients with PD-L1 (combined positive score [CPS] ≥10), as determined by an FDA-approved test.
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On October 14, 2020, the FDA expanded the approval of pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, for the treatment of relapsed or refractory classical Hodgkin lymphoma in adults and for refractory classical Hodgkin lymphoma or classical Hodgkin lymphoma in pediatric patients that has relapsed after receiving ≥2 lines of therapy. The FDA granted pembrolizumab orphan drug and breakthrough therapy designations for this indication.
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On October 2, 2020, the FDA approved the combination of nivolumab (Opdivo; Bristol Myers Squibb), a PD-1 inhibitor, and ipilimumab (Yervoy; Bristol Myers Squibb), a CTLA-4 inhibitor, for first-line treatment of adults with unresectable malignant pleural mesothelioma.
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In October and November, the FDA approved FoundationOne Liquid CDx (Foundation Medicine), a next-generation sequencing liquid biopsy test, for the identification of multiple cancers and biomarkers.
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On October 23, 2020, the FDA approved the FoundationOne CDx diagnostic test as a companion diagnostic to identify fusions in the NTRK1, NTRK2, and NTRK3 genes in patients who are eligible for treatment with larotrectinib (Vitrakvi).
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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.
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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.
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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.
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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.
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  • Inqovi First Oral Hypomethylating Agent Approved for Intermediate- or High-Risk Myelodysplastic Syndromes
  • Zepzelca New Therapy Approved for Metastatic Small-Cell Lung Cancer
  • Opdivo Now Approved for Advanced Esophageal Squamous-Cell Carcinoma
  • Cyramza plus Tarceva Approved for First-Line Treatment of Metastatic NSCLC with EGFR Mutation
  • Tecentriq plus Avastin Combination Approved for First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma
  • Opdivo plus Yervoy and Limited Chemotherapy Approved as First-Line Therapy for Metastatic NSCLC, Regardless of PD-L1 Expression
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