FDA Approvals, News & Updates

On August 13, 2021, the FDA approved belzutifan (Welireg; Merck), an oral hypoxia-inducible factor inhibitor, for the treatment of adults with von Hippel-Lindau (VHL) disease that is associated with 1 of 3 tumor types that are not requiring immediate surgery, including renal-­cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET). Read Article ›

On September 17, 2021, the FDA accelerated the approval of a new indication for cabozantinib (Cabometyx; Exelixis) for the treatment of patients aged ≥12 years with locally advanced or metastatic differentiated thyroid cancer that has progressed after VEGFR-targeted therapy and who are ineligible for, or whose disease is refractory to, radioactive iodine. The FDA granted cabozantinib breakthrough therapy and orphan drug designations for this indication. Read Article ›

On September 14, 2021, the FDA accelerated the approval of zanubrutinib (Brukinsa; BeiGene) for adults with relapsed or refractory marginal-zone lymphoma (MZL) who have received ≥1 anti-CD20–based regimens. Two weeks earlier, on August 31, 2021, the FDA accelerated the approval of zanubrutinib for adults with Waldenström’s macroglobulinemia (WM). Zanubrutinib received an orphan designation for these indications. Read Article ›

On August 19, 2021, the FDA accelerated the approval of nivolumab (Opdivo; Bristol Myers Squibb) for the adjuvant treatment of patients with urothelial carcinoma who are at high risk for recurrence after undergoing radical resection. This is the first FDA approval of any immunotherapy for adjuvant treatment of patients with high-risk urothelial carcinoma. Read Article ›

On August 17, 2021, the FDA accelerated the approval of dostarlimab-gxly (Jemperli; GlaxoSmithKline) for adults with mismatch repair-deficient (dMMR), as determined by an FDA-approved test, recurrent or advanced solid tumor that progressed during or after treatment for whom there are no satisfactory alternative options. Read Article ›

On August 10, 2021, the FDA accelerated the approval of the combination of lenvatinib (Lenvima; Eisai) and pembrolizumab (Keytruda; Merck) for the first-line treatment of adults with advanced RCC. This combination received a breakthrough therapy designation for this indication. Read Article ›


On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication. Read Article ›

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase. The FDA granted asparaginase erwinia a fast-track review and an orphan drug designation for this indication. Read Article ›

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck), for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. Read Article ›

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