Revolution Medicines Gets FDA Breakthrough Designation for Cancer Treatment
By Katherine Hamilton
Revolution Medicines received breakthrough therapy designation from the Food and Drug Administration for its treatment of pancreatic cancer.
The designation is for Rasonque to treat metastatic pancreatic adenocarcinoma (PDAC), a form of pancreatic cancer, in combination with gemcitabine and nab-paclitaxel.
Rasonque was recently approved by the FDA to treat adults with metastatic PDAC who have received at least one prior systemic therapy or who aren't candidates for multiagent systemic therapy.
The breakthrough designation is based on data from a Phase 1-2 trial, where the treatment showed encouraging preliminary anti-tumor activity and a manageable safety profile. The data from that trial informed the design of a Phase 3 trial.
Breakthrough therapy designation is intended to speed up the development and review of a potential new medicine for serious conditions and unmet medical needs.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
September 14, 2026 17:01 ET (21:01 GMT)
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