“A new drug for metastatic pancreatic cancer nearly doubled survival time in a phase 3 trial, with patients living for a median of 13.2 months after treatment began compared to 6.7 months on standard chemotherapy,” reports The Doomslayer.
“Pancreatic cancer is the most RAS-addicted of all major cancers, with more than 90% of patients harboring tumors driven by mutations in RAS proteins. These mutations span a range of RAS variants that fuel aggressive tumor behavior,” the drugmaker notes. It explains that
Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced positive topline results from its global, randomized, controlled Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who had been previously treated. Daraxonrasib taken orally once daily demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care cytotoxic chemotherapy delivered intravenously. In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). Daraxonrasib was generally well tolerated, with a manageable safety profile.
Based on the results from this first interim analysis, all PFS and OS endpoint results are considered final. Revolution Medicines intends to submit these data to global regulatory authorities, including to the U.S. Food and Drug Administration as part of a future New Drug Application under a Commissioner’s National Priority Voucher.
The drug has not been approved by the FDA yet. Many people die waiting for the FDA to approve medical tests and life-saving drugs. The FDA can be rather slow. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff noted in Fortune, the FDA’s delay in approving the home HIV test was a “scandal.” It caused the deaths of thousands of people.
At least a hundred thousand people died waiting years for the FDA to approve beta blockers in the 20th Century. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to deliberately delay drug approvals and other people, such as his habit of deliberately driving slowly in the fast lane on highways in order to slow down other motorists.
An mRNA vaccine saves the lives of pancreatic cancer patients. A cancer researcher recently home-brewed a beer that works as a vaccine.
Moderna is developing a cancer vaccine that is expected to dramatically cut cancer survivors’ risk of death or recurrence. It is also an mRNA vaccine.
A new lung-cancer drug radically increases survival rates. New personalized cancer vaccines cut death rates by 40-50% for some people suffering from skin or breast cancer.
Deadly brain cancer survival times improve with ultrasound.
