FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%

Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient groups for which it is approved.

Rasonque received FDA approval in August based on a trial that showed it nearly doubled overall survival compared with standard chemotherapy in patients who had progressed after prior treatment.

The new FDA data indicate that the drug’s benefit varies by KRAS mutation. Tumor responses were strongest in patients with the G12V mutation, more modest in those with G12D – the most common form of pancreatic cancer – and weaker still in patients with the G12R mutation.

Despite the sell‑off, several Wall Street analysts described the market reaction as an overreaction, arguing that the drug still offers a meaningful option for many patients.