FDA Approvals, News & Updates

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 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.

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.

On May 25, 2022, the FDA accelerated the approval of ivosidenib tablets (Tibsovo; Servier Pharmaceuticals), in combination with azacitidine tablets (Onureg; Celgene) for newly diagnosed acute myeloid leukemia (AML) and a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients aged ≥75 years, or patients with comorbidities that preclude the use of intensive induction chemotherapy.

On May 27, 2022, the FDA accelerated the approval of a new indication for the CD19-directed CAR T-cell therapy tisagenlecleucel (Kymriah; Novartis) for adults with relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy.

On May 20, 2022, the FDA accelerated the approval of a new indication for azacitidine injection (Vidaza; Celgene) for the treatment of pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

On May 4, 2022, the FDA granted a regular full approval for fam-trastuzumab deruxtecan-nxki (Enhertu; Daiichi Sankyo), an HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who had received a prior anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and who had developed disease recurrence during or within 6 months of completing therapy.

On April 1, 2022, the FDA accelerated the approval of a new indication for the CAR T-cell therapy axicabtagene ciloleucel (Yescarta; Kite Pharma) for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.