FDA clears daily pill for pancreatic cancer after 13.2-month trial survival
What's new: The drug won priority review and was cleared more than six months before the FDA's deadline.
The Food and Drug Administration approved Rasonque, a once-daily pill from California-based Revolution Medicines, for adults with metastatic pancreatic adenocarcinoma whose disease progressed after prior treatment or who could not receive certain combination therapies. The agency said the drug targets multiple forms of the RAS protein, a main driver of tumor growth in the most common kind of pancreatic cancer. In a 500-patient trial, people given Rasonque had median overall survival of 13.2 months, compared with 6.7 months for a standard chemotherapy group. The FDA granted the medicine priority review, orphan drug status and breakthrough therapy designation, and cleared it 6 1/2 months ahead of schedule.