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FDA approves Rasonque for metastatic pancreatic cancer
The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a breakthrough once-daily pill developed by Revolution Medicines for treating adults with metastatic pancreatic adenocarcinoma. This marks the first medicine to directly target the RAS protein, which drives the growth of most pancreatic cancers.
The approval follows results from the Phase 3 RASolute 302 clinical trial. Data showed that Rasonque significantly improved outcomes compared to standard chemotherapy, reducing the risk of death by 60 percent. Patients treated with the drug achieved a median overall survival of 13.2 months, compared to 6.7 months for those on chemotherapy.
The medication is intended for patients who have previously undergone systemic therapy or are ineligible for combination chemotherapy. While approved in the U.S., the drug remains investigational elsewhere; the European Medicines Agency (EMA) has initiated a phased review to determine future availability in Europe and the Nordic regions.
Entities
EMA · FDA · Kyle Diamantas · Mark A. Goldsmith · National Cancer Institute · RAS protein · Rasonque · Rasonque · Revolution Medicines · daraksonrasib · daraxonrasib
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 6 SOURCES] The FDA granted accelerated approval to daraksonrasib (Rasonque). cuvajzdravlje.ba · www.zdravezpravy.cz · www.zdravotnickydenik.cz · wiadomosci.wp.pl · www.viendongdaily.com · +1 more
- [● 6 SOURCES] The drug is intended for patients with metastatic pancreatic cancer who failed previous therapies. cuvajzdravlje.ba · www.zdravezpravy.cz · www.zdravotnickydenik.cz · wiadomosci.wp.pl · www.viendongdaily.com · +1 more
- [● 4 SOURCES] Daraksonrasib is developed by Revolution Medicines. www.zdravezpravy.cz · www.zdravotnickydenik.cz · www.viendongdaily.com · nordiclifescience.org
- [● 3 SOURCES] Median survival for patients on daraksonrasib was 13.2 months. cuvajzdravlje.ba · wiadomosci.wp.pl · nordiclifescience.org
- [● 3 SOURCES] The EMA is currently conducting an accelerated assessment in Europe. www.zdravotnickydenik.cz · wiadomosci.wp.pl · nordiclifescience.org
- [● 6 SOURCES] The medication is administered as a once-daily pill. cuvajzdravlje.ba · www.zdravezpravy.cz · www.zdravotnickydenik.cz · wiadomosci.wp.pl · www.viendongdaily.com · +1 more
- [● 2 SOURCES] The drug nearly doubled survival compared to standard chemotherapy, which had a median of 6.7 months. cuvajzdravlje.ba · nordiclifescience.org
- [● 6 SOURCES] The drug targets RAS/KRAS proteins to inhibit tumor growth. cuvajzdravlje.ba · www.zdravezpravy.cz · www.zdravotnickydenik.cz · wiadomosci.wp.pl · www.viendongdaily.com · +1 more
- [○ 1 SOURCE] RASONQUE cut the risk of death by 60 percent compared to chemotherapy. nordiclifescience.org