The Lynx Group

October 2022, Vol 13, No 5

On September 30, 2022, the FDA accelerated the approval of futibatinib (Lytgobi; Taiho Oncology), a tyrosine kinase inhibitor, for the treatment of previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (CCA) in adults with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other arrangements.
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On August 10, 2022, the FDA accelerated the regular full approval of capmatinib (Tabrecta; Novartis), a tyrosine kinase inhibitor, for the treatment of metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have MET exon 13 skipping mutation, as detected by an FDA-approved test.
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On September 21, 2022, the FDA accelerated the approval of selpercatinib (Retevmo; Eli Lilly), a RET kinase inhibitor, for the treatment of locally advanced or metastatic solid tumors with a RET gene fusion in patients whose disease has progressed while or after receiving systemic treatment or who have no alternative treatment options.
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On September 2, 2022, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1–blocking antibody, in combination with gemcitabine and cisplatin, for the treatment of locally advanced or metastatic biliary tract cancer in adults.
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On August 26, 2022, the FDA accelerated the approval of pemigatinib (Pemazyre; Incyte Corporation), a tyrosine kinase inhibitor, for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR)1 rearrangement in adults.
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On August 24, 2022, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for the treatment of chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 years who have not responded to ≥1 lines of systemic treatment.
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On August 11, 2022, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic non–small-cell lung cancer (NSCLC) in adults whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have previously received systemic therapy.
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On August 5, 2022, the FDA accelerated the approval of fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), a human epidermal growth factor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, for the treatment of unresectable or metastatic HER2-low (immunohistochemistry [IHC]1-positive or IHC2-positive/in situ hybridization–negative) breast cancer in adults who have previously received chemotherapy in the metastatic setting or who have had disease recurzrence during or within 6 months of completing adjuvant chemotherapy.
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On August 5, 2022, the FDA accelerated the approval of darolutamide (Nubeqa; Bayer Healthcare), an androgen receptor inhibitor, in combination with docetaxel, for the treatment of metastatic hormone-sensitive prostate cancer in adults. Darolutamide was previously approved for the treatment of nonmetastatic castration-resistant prostate cancer.
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