FDA Approvals, News & Updates

On October 29, 2021, the FDA granted accelerated approval to asciminib (Scemblix; Novartis) for patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, previously treated with ≥2 tyrosine kinase inhibitors (TKIs). The drug was also granted a full approval for adult patients with Ph+ CML in chronic phase with a T315I mutation. Read Article ›

On September 20, 2021, the FDA accelerated the approval of tisotumab vedotin-tftv (Tivdak; Seagen), a tissue factor-directed antibody and microtubule inhibitor conjugate, for the treatment of women with recurrent or metastatic cervical cancer whose disease progressed during or after chemotherapy. Read Article ›

On October 15, 2021, the FDA approved a new indication for atezolizumab (Tecentriq; Genentech) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non–small-cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥1% of tumor cells, as determined by an FDA-approved test. Read Article ›

On October 13, 2021, the FDA approved a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for use in combination with chemotherapy, with or without bevacizumab (Avastin; Genentech), for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Read Article ›

On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio; Eli Lilly), in combination with tamoxifen or an aromatase inhibitor as initial endocrine-based therapy, for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive, early breast cancer at high risk for recurrence, and a Ki-67 score ≥20%, as determined by an FDA-approved test. Read Article ›

On September 22, 2021, the FDA approved a new indication for ruxolitinib (Jakafi; Incyte) for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after 1 or 2 lines of systemic therapy. Ruxolitinib received an orphan drug designation for this indication. Read Article ›

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 Article ›

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 ›

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