The FDA approved dostarlimab in rectal cancer and pembrolizumab in tumors with high mutational burden, Europe cleared teclistamab in myeloma, and more.
News|Articles|August 1, 2025
OncLive’s July Roundup of Key FDA Approvals in Oncology: 4 Decisions to Know
Author(s)OncLive Staff
Fact checked by: Kristi Rosa
Here is your guide to all therapeutic options that were approved by the FDA in July 2025 spanning tumor types.
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Below is your guide to all the oncologic therapeutic options approved by the FDA in July 2025. The roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights contextualizing what they mean for clinical practice.
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The FDA granted breakthrough therapy designation to enzomenib for relapsed/refractory acute leukemia with a KMT2A rearrangement.
Sac-TMT plus pembrolizumab prolonged PFS over chemoimmunotherapy in PD-L1–negative nonsquamous lung cancer.
The FDA received a BLA for etentamig in relapsed/refractory multiple myeloma, based on response and PFS gains in the phase 3 CERVINO trial.
Elranatamab improved PFS vs 3 standard regimens in relapsed/refractory multiple myeloma in the phase 3 MagnetisMM-32 trial.
Adjuvant pembrolizumab continued to extend DFS in resected stage IB to IIIA NSCLC, though OS did not differ from placebo.
Longer DeLLphi-304 follow-up showed sustained OS, PFS, and response durability with tarlatamab in second-line small cell lung cancer.
Izalontamab brengitecan improved progression-free survival vs chemotherapy in EGFR-mutated lung cancer after a third-generation EGFR inhibitor.
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