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BREAKING NEWS: On April 5, 2024, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2+ (IHC3+) solid tumors after prior treatment and no satisfactory alternative treatment options. Approval was based on the DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials.
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On March 1, 2024, the FDA approved amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.) with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, based on the PAPILLION trial.
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On March 6, 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC) based on the CHECKMATE-901 study.
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On March 14, 2024, the FDA approved tislelizumab-jsgr (Tevimbra, BeiGene) a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. Approval was based on the phase 3 RATIONALE 302 trial.
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On March 19, 2024, the FDA granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) based on the PhALLCON trial.
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On March 21, 2024 the FDA updated the label of fluorouracil to warn of serious and potentially fatal adverse events in patients with dihydropyrimidine dehydrogenase deficiency.
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On March 22, 2024, the FDA granted full approval to miretuximab soravtansine (Elahere, ImmunoGen, Inc.) for patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior lines of treatment.
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