FDA Approvals, News & Updates

Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations.

On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. This is the first indication for brentuximab vedotin for pediatric patients. Brentuximab vedotin has an orphan drug designation for Hodgkin lymphoma.

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.

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.

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.

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.

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.

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.

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.

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.