FDA approves daraxonrasib for metastatic pancreatic cancer

pancreatic cancer daraxonrasib Rasonque RAS inhibitor FDA approval

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to daraxonrasib, marketed under the brand name Rasonque, for the treatment of adults with metastatic pancreatic adenocarcinoma. Developed by Revolution Medicines, the drug is a once-daily oral tablet that functions as a RAS inhibitor, specifically targeting mutations in the RAS protein family that drive tumor growth.

Clinical data from the phase 3 RASolute 302 trial, which involved 500 patients, demonstrated significant efficacy. Patients receiving daraxonrasib achieved a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy. The study also reported an objective response rate of 30%, significantly higher than the 11% observed in the control group, and a reduction in the risk of death by approximately 60%.

While the drug offers a new therapeutic option for a disease historically considered difficult to treat, some patients have reported side effects including skin redness, diarrhea, and gastrointestinal issues. In the United States, a 30-day supply of Rasonque is priced at $39,800.

Entities

FDA · Rasonque · Rasonque · Revolution Medicines · United States · daraxonrasib · daraxonrasib

Claims

What the coverage asserts, and how many sources carry each claim.

[● 7 SOURCES] Patients treated with daraxonrasib had a median overall survival of 13.2 months compared to 6.7 months with standard chemotherapy. fjala.al · www.ad-hoc-news.de · telegrafi.com · www.agriniosite.gr · www.yenivatan.at · +2 more
[● 2 SOURCES] The drug achieved an objective response rate of 30% compared to 11% in the chemotherapy group. www.ad-hoc-news.de · telegrafi.com
[● 5 SOURCES] The RASolute 302 phase 3 clinical trial included 500 patients with metastatic pancreatic cancer. fjala.al · www.ad-hoc-news.de · telegrafi.com · www.yenivatan.at · infovilag.hu
[● 4 SOURCES] Daraxonrasib is a once-daily oral tablet that targets RAS family proteins. fjala.al · telegrafi.com · www.vanityfair.it · www.agriniosite.gr
[● 9 SOURCES] The FDA approved daraxonrasib (Rasonque) for treating adults with metastatic pancreatic adenocarcinoma. fjala.al · que.com · www.ad-hoc-news.de · telegrafi.com · www.vanityfair.it · +4 more
[● 4 SOURCES] The FDA granted approval through an accelerated procedure. fjala.al · www.ad-hoc-news.de · telegrafi.com · www.agriniosite.gr
[● 2 SOURCES] The cost of a 30-day supply of Rasonque in the United States is $39,800. fjala.al · telegrafi.com
[● 2 SOURCES] The drug reduced the risk of death by approximately 60% compared to the control group. fjala.al · www.ad-hoc-news.de