Revolution Medicines Lands FDA Breakthrough for Daraxonrasib in KRAS G12‑Mutant Metastatic Pancreatic Cancer

The FDA has granted Breakthrough Therapy designation to Daraxonrasib, an oral RAS(ON) inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12X mutations. In Phase 1 (RMC-6236-001), second‑line metastatic PDAC (progressed within six months of prior therapy), median PFS was 8.1 months (95% CI, 5.9–NE) for KRAS G12X and 7.6 months (95% CI, 5.3–NE) for all RAS‑mutated cases. For third‑line or later treatment with RMC‑6236, median PFS was 4.2 months (95% CI, 4.1–6.4). Among second‑line+ patients with KRAS G12X, ORR reached 20% (16/79) at ≥14 weeks and 27% (13/48) at ≥20 weeks, with a 14‑week DCR of 87%.

The global Phase 3 RASolute‑302 trial is ongoing, comparing daraxonrasib to standard chemotherapy in G12X (plus expanded G13X and Q61X) cohorts, with dual primary endpoints of PFS and OS. Topline results are expected in 2026. (Reference: Revolution Medicines, Inc. “Revolution Medicines Announces FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations.” GlobeNewswire, 23 June 2025)

Amgen Reveals Positive Phase 3 Bemarituzumab Data in FGFR2b-positive Gastric Cancer

Amgen’s Phase III FORTITUDE‑101 trial met its primary endpoint, demonstrating a significant overall survival benefit when Bemarituzumab was added to mFOLFOX6 in FGFR2b-overexpressing, HER2-negative gastric or gastroesophageal junction cancer.
The 547-patient study selected tumors with ≥10% FGFR2b positivity; ocular events (like keratitis and vision changes) and hematologic toxicities were more common in the treatment arm. Detailed efficacy and safety data, along with results from an upcoming chemo+nivolumab combo study, are expected later this year. (Reference: Amgen Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b)‑Positive First‑Line Gastric Cancer.” Amgen Press Release, 30 June 2025.)

FDA Lifts REMS for CAR‑T Therapies

As of June 27, the FDA removed REMS requirements for all FDA-approved BCMA- and CD19-directed autologous CAR‑T therapies—Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta .
Key changes:

(Reference: U.S. Food and Drug Administration. “FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies.” FDA Press Release, 27 June 2025.)

FDA Grants Accelerated Approval to Sunvozertinib (Zegfrovy) for EGFR Exon 20+ NSCLC

On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, following disease progression on platinum-based chemotherapy.
In the WU‑KONG1B trial (n=85), sunvozertinib showed a 46% ORR and median duration of response of 11.1 months. The FDA also approved a companion diagnostic to identify eligible patients. (Reference: U.S. Food and Drug Administration. “FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non‑Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.” FDA Press Release, 2 July 2025.)

Lynozyfic (Linvoseltamab‑gcpt) Joins Myeloma Armamentarium

The FDA granted accelerated approval to Linvoseltamab‑gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.) on July 2, 2025, for adult patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, IMiD, and anti‑CD38 antibody.
In the LINKER‑MM1 trial, the BCNMA×CD3 engager achieved a 70% ORR, With a median follow-up of 11.3 months among responders, the estimated duration of response (DOR) was 89% (95% CI: 77, 95) at 9 months and 72% (95% CI: 54, 84) at 12 months. (Reference: U.S. Food and Drug Administration. “FDA Grants Accelerated Approval to Linvoseltamab‑gcpt for Relapsed or Refractory Multiple Myeloma.” FDA Press Release, 2 July 2025.)

This week’s Oncology Spotlight: Dr. Paul O’Brien’s Unconventional Journey into Medicine (Click here to watch)

Dr. Paul O’Brien’s journey—from food science to clinical medicine across China and Ireland now fuels his mission to combat medical misinformation. On Oncology Spotlight, he discusses resilience from his training Square Artwork , an open‑letter moment, AI in decision‑making, and the fight back against pseudoscience and viral influencers. His story is a powerful call for physicians to reclaim the social‑media narrative.

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Revolution Medicines Lands FDA Breakthrough for Daraxonrasib in KRAS G12‑Mutant Metastatic Pancreatic Cancer