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Commentary|Articles|February 13, 2025
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- Perspectives on FDA Oncology Approvals and Withdrawals That Shaped 2024: A Year in Review Roundup
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2024 FDA Approvals in Breast, Gynecologic, and Other Solid Tumors Represent Key Steps Forward
Author(s)Megan Hollasch
Fact checked by: Caroline Seymour
Experts provide insights on the 2024 FDA approvals in several different fields including solid tumors and more in this list featuring the regulatory decisions.
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The first ever tumor-infiltrating lymphocyte (TIL) therapy to receive the go-ahead from the FDA, lifileucel (Amtagvi), gained an indication for patients with melanoma in 2024, marking an important milestone in a year with many. There were more than 65 accelerated, regular, or expanded approvals over the 365 days, and selpercatinib (Retevmo) was one of 6 agents that snagged 3 approvals. Two approvals in the brain cancer field also represented notable regulatory decisions—vorasidenib (Voranigo) was the first systemic therapy that received the greenlight from the FDA for patients with low-grade glioma in more than 20 years.
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