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FDA approves daraxonrasib for metastatic pancreatic cancer treatment
The U.S. Food and Drug Administration (FDA) has approved 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 RAS inhibitor designed to target mutations in the RAS protein family, which are present in over 90% of pancreatic cancer cases.
The approval is based on results from the phase 3 RASolute 302 clinical trial involving 500 patients. Data showed 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. The treatment also demonstrated a 60% reduction in the risk of death and an objective response rate of 30%, compared to 11% in the control group.
Rasonque is indicated for patients who have received at least one prior systemic therapy or those who are not candidates for combination chemotherapy. The drug was approved via an accelerated FDA procedure. In the United States, a 30-day supply of the medication 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.
- [● 3 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
- [● 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
- [● 3 SOURCES] The RASolute 302 phase 3 clinical trial included 500 patients with metastatic pancreatic cancer. fjala.al · www.ad-hoc-news.de · telegrafi.com
- [● 3 SOURCES] Daraxonrasib is a once-daily oral tablet that targets RAS family proteins. fjala.al · telegrafi.com · www.vanityfair.it
- [● 5 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
- [● 3 SOURCES] The FDA granted approval through an accelerated procedure. fjala.al · www.ad-hoc-news.de · telegrafi.com
- [● 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