FDA Approvals, News & Updates
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 More ›
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 More ›
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 More ›
On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda), an oral kinase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease progressed during or after platinum-based chemotherapy. Mobocertinib received breakthrough therapy and orphan drug designations for this indication. Read More ›
On July 9, 2021, the FDA granted full approval to enfortumab vedotin-ejfv (Padcev; Astellas Pharma) Read More ›
On June 16, 2021, the FDA approved a new indication for avapritinib (Ayvakit; Blueprint Medicines) for the treatment of adults with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis, systemic mastocytosis with an associated hematologic neoplasm, and mast-cell leukemia. The FDA granted this indication a priority review and breakthrough therapy and orphan drug designations. Read More ›
On July 9, 2021, the FDA accelerated the approval of a new indication for daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech), in combination with pomalidomide (Pomalyst; Bristol Myers Squibb) and dexamethasone, for the treatment of adults with multiple myeloma who have received ≥1 previous lines of therapy, including lenalidomide (Revlimid) or a proteasome inhibitor. Daratumumab and hyaluronidase, as well as pomalidomide, are each already approved for the treatment of patients with multiple myeloma, alone or in combination with other drugs. Read More ›
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 More ›
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 More ›
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 More ›