The Lynx Group

FDA Approvals, News & Updates

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.
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On November 25, 2020, the FDA granted accelerated approval to naxitamab-gqgk (Danyelza; Y-mAbs Therapeutics), a GD2-binding monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients aged ≥1 year and adults who achieved a partial response, minor response, or stable disease after receiving previous therapy. The FDA granted naxitamab priority review and breakthrough therapy, orphan drug, and rare pediatric disease designations.
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On September 1, 2020, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.
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On December 1, 2020, the FDA accelerated the approval of a new indication for pralsetinib (Gavreto; Blueprint Medicines), a RET kinase inhibitor, for the treatment of patients aged ≥12 years with advanced or metastatic medullary thyroid cancer and RET mutation who require systemic therapy or for patients with thyroid cancer and RET fusion who require systemic therapy and whose tumor is refractory to radioactive iodine, if radioactive iodine is appropriate.
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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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