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On January 12, 2024, the FDA approved pembrolizumab (Keytruda®, Merck) plus external beam radiotherapy and concurrent chemotherapy as a treatment for patients with newly diagnosed, high-risk, locally advanced cervical cancer. The approval is supported by the KEYNOTE-A18 trial, a randomized, phase 3, double-blind, placebo-controlled study.
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On January 19, 2024, the FDA approved erdafitinib (Balversa®, Janssen Biotech) for the treatment of locally advanced or metastatic urothelial carcinoma with FGFR3 genetic alteration, as determined by an FDA-approved companion diagnostic test, who have experienced disease progression on or after at least one line of prior systemic treatment.
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On February 13, 2024, the FDA approved iposomal irinotecan (Onivyde®, Ipsen Biopharmaceuticals) with 5-fluorouracil (5-FU), leucovorin, and oxaliplatin as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) based on data from the phase 3 NAPOLI 3 trial.
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On February 15, 2024, the FDA granted full approval to tepotinib (Tepmetko®, Merck) for patients with metastatic NSCLC harboring MET exon 14 skipping alterations based on data from the VISION trial.
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On February 16, 2024, the FDA approved osimertinib (Tagrisso®, AstraZeneca Pharmaceuticals) with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test based on the Flaura2 trial.
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On February 16, 2024, the FDA granted accelerated approval for lifileucel (Amtagvi™, Iovance Biotherapeutics) for adults with unresectable or metastatic melanoma who have been previously treated with a PD-1 blocking antibody, and if BRAF V600-positive, a BRAF inhibitor with or without a MEK inhibitor.
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On February 20, 2024, the FDA approved a reduced dosing frequency of 1.5 mg/kg every 2 weeks for teclistamab-cqyv (TECVAYLI®, Janssen) in patients with relapsed/refractory multiple myeloma who have sustained a complete response or better for at least 6 months based on the MajesTEC-1 trial.
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