FDA approves Rasonque for metastatic pancreatic cancer

pancreatic cancer daraxonrasib Rasonque RAS inhibitors FDA approval

The U.S. Food and Drug Administration (FDA) has approved daraxonrasib, marketed as Rasonque, for the treatment of adults with metastatic pancreatic adenocarcinoma. Developed by Revolution Medicines, the drug is a first-of-its-kind oral pill that acts as a multi-selective RAS inhibitor, targeting the RAS protein responsible for tumor growth in over 90% of pancreatic cancer cases.

The approval follows results from the Phase 3 RASolute 302 clinical trial involving 500 patients. The study demonstrated that patients receiving daraxonrasib had a median overall survival of 13.2 months, nearly doubling the 6.7 months observed in those receiving standard chemotherapy. Additionally, the treatment showed a 60% reduction in the risk of death and a median progression-free survival of 7.2 months, compared to 3.6 months for the chemotherapy group.

FDA officials granted expedited approval through programs such as Breakthrough Therapy and Real-Time Oncology Review, completing the process approximately 6.5 months ahead of the target date. Rasonque is indicated for patients who have received prior systemic therapy or are ineligible for combination chemotherapy. In the United States, a 30-day supply is priced at approximately $39,800.

Entities

American Cancer Society · FDA · Food and Drug Administration · KRAS · Pancreatic Cancer Action Network · RAS protein · RAS protein · Rasonque · Rasonque · Revolution Medicines · daraxonrasib · daraxonrasib

Claims

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

[● 2 SOURCES] Patates Köftesi is a meatless, vegetarian version of traditional Turkish köfte.
[● 2 SOURCES] Patates Köftesi uses mainly waxy potatoes combined with spices such as cumin, paprika, oregano, or cinnamon.
[● 3 SOURCES] Patients treated with daraxonrasib had a median survival of 13.2 months, compared to 6.7 months for those receiving chemotherapy. vinnews.com
[● 3 SOURCES] The American Cancer Society estimates 67,000 new pancreatic cancer cases will be diagnosed in the U.S. this year. vinnews.com
[● 3 SOURCES] The FDA granted expedited approval to the pancreatic cancer drug daraxonrasib. vinnews.com
[● 3 SOURCES] The FDA approved the drug more than six months ahead of its target date. vinnews.com
[● 3 SOURCES] The drug blocks a mutated protein that fuels tumor growth in over 90% of pancreatic cancer cases. vinnews.com
[● 3 SOURCES] Revolution Medicines will market the drug under the brand name Rasonque. www.mediapress24.it · vinnews.com
[● 15 SOURCES] The FDA approved daraxonrasib (Rasonque) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic療法. tetova1.mk · pulptastic.com · tiempodigital.mx · pancreatic.org · www.stocktitan.net
[○ 1 SOURCE] Rasonque is the first RAS inhibitor approved by the FDA for cancer therapy. pancreatic.org
[● 9 SOURCES] Common adverse reactions to the drug include rash, diarrhea, and stomatitis. www.stocktitan.net · www.kaaltv.com · www.lewistownsentinel.com · www.dnews.gr · svevijesti.ba · +3 more
[● 30 SOURCES] Rasonque is a once-daily oral tablet. pulptastic.com · tiempodigital.mx · pancreatic.org · www.stocktitan.net · ch23.com · +18 more