Japan patients petition for early approval of pancreatic cancer drug

Patients and families in Japan are campaigning for the early approval of darlaxonrasib, a breakthrough pancreatic cancer drug that received approval in the United States in August. Clinical trials have shown the drug can potentially double survival rates for patients who have exhausted primary chemotherapy options, extending life expectancy from approximately six months to thirteen months.

An online petition calling for the application of the “conditional early approval” system has gathered over 4,000 signatures, including support from actor Yasushi Yasuda. While the drug was designated as an orphan drug by Japan’s Ministry of Health, Labour and Welfare in May, the specific timeline for domestic approval remains uncertain. The Ministry has declined to comment on the current status of individual applications.

Because the drug underwent international clinical trials involving Japanese medical institutions, such as the National Cancer Center Hospital Ariake, and the PMDA participated as an observer, experts suggest the hurdles for domestic approval may be relatively low.