The FDA has granted designations for cancer drug therapies addressing pancreatic cancer and melanoma.
- Verastem Oncology received an orphan drug designation from the FDA for its combination avutometinib and defactinib drug therapy for the treatment of pancreatic cancer, according to a July 29 news release from the company.
An orphan drug designation is granted to investigative treatments for diseases that affect fewer than 200,000 people in the U.S. Pancreatic cancer affects more than 30,000 U.S. patients per year and has a 3% five-year survival rate.
The combination therapy is in trial. The company said it will release updated trial data in the first quarter of 2025. - Obsidian Therapeutics received a fast track designation from the FDA for its OBX-115 immunotherapy drug for the treatment of metastatic or locally advanced melanoma, according to a July 9 news release from the company.
The designation expedites the development and review of new drug therapies designed to treat life-threatening conditions.
OBX-115 is in two clinical trials, for advanced or metastatic melanoma and non-small cell lung cancer.