FDA Approvals, News & Updates

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.