The Lynx Group

FDA Approvals, News & Updates

On October 29, 2021, the FDA granted accelerated approval to asciminib (Scemblix; Novartis) for the treatment of patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, previously treated with ≥2 tyrosine kinase inhibitors.
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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.
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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.
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On October 12, 2021, the FDA approved a new indication for the cyclin-dependent kinase 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-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.
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On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.
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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.
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On August 31, 2021, the FDA approved zanubrutinib (Brukinsa; BeiGene), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with Waldenström’s macroglobulinemia. Zanubrutinib was previously approved for the treatment of adults with mantle-cell lymphoma.
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On August 25, 2021, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral IDH1 inhibitor, for the treatment of adults with previously treated, locally advanced or metastatic cholangiocarcinoma (CCA) and an IDH1 mutation, as detected by an FDA-approved test. The FDA granted ivosidenib a priority review for this indication and an orphan drug designation.
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On August 10, 2021, the FDA approved the combination of lenvatinib (Lenvima; Eisai) plus pembrolizumab (Keytruda; Merck) for the first-line treatment of adults with advanced renal-cell carcinoma (RCC). The FDA granted this combination a priority review and breakthrough therapy designation.
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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.
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