The Lynx Group

FDA Approvals, News & Updates

The Centers for Medicare & Medicaid Services (CMS) has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their physicians without having to travel to a healthcare facility. Clinicians can bill immediately for services starting March 6, 2020.
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On March 2, 2020, the FDA approved isatuximab-irfc (Sarclisa; Sanofi-Aventis), a CD38-directed cytolytic antibody, for the treatment of adults with multiple myeloma, for use in combination with pomalidomide (Pomalyst) and dexamethasone, in patients who had received at least 2 therapies that included lenalidomide (Revlimid) and a proteasome inhibitor. The FDA granted isatuximab an orphan drug designation.
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On January 23, 2020, the FDA accelerated the approval of tazemetostat (Tazverik; Epizyme Inc), an EZH2 methyltransferase blocker, for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma (a subtype of soft-tissue sarcoma) that is not eligible for complete resection. Tazemetostat received an orphan drug designation for this indication.
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On January 9, 2020, the FDA accelerated the approval of avapritinib (Ayvakit; Blueprint Medicines Corporation), a kinase inhibitor, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. The FDA granted breakthrough therapy and orphan drug designations to avapritinib.
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On December 23, 2019, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer after ≥2 previous anti-HER2–based regimens in the metastatic setting. The FDA granted fam-trastuzumab deruxtecan-nxki a breakthrough therapy designation.
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On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.
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On January 8, 2020, the FDA accelerated the approval of a new indi­cation for pembrolizumab (Keytruda; Merck & Co) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer and carcinoma in situ, with or without papillary tumors, in patients who are ineligible for or who have elected not to undergo cystectomy. Pembrolizumab has been previously approved for many indications.
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On December 27, 2019, the FDA accelerated the approval of a new indication for olaparib (Lynparza; AstraZeneca) for the maintenance treatment of adults with metastatic pancreatic adenocarcinoma associated with a deleterious or suspected deleterious germline BRCA mutation, as detected by an FDA-approved test, and whose disease did not progress during ≥16 weeks of a first-line platinum-based chemotherapy regimen. Olaparib has been previously approved for ovarian cancer and for breast cancer associated with BRAF mutation.
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On December 16, 2019, the FDA approved a new indication for enzalutamide (Xtandi; Astellas Pharma) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Enzalutamide was previously approved for patients with castration-­resistant prostate cancer.
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On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer.
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