[REVISION HISTORY]
FDA approves Rasonque; EMA recommends for pancreatic cancer
15 recorded revisions of this situation.
What changed
2026-10-19 03:12 UTC → 2026-10-21 03:12 UTC ·
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removed
On 26 August 2026, the U.S. Food and Drug Administration (FDA) granted expedited approval to daraxonrasib, marketed as Rasonque, for treating adults with metastatic pancreatic ductal adenocarcinoma (PDAC). Developed by Revolution Medicines, this once-daily oral pill is the first targeted therapy approved to inhibit the RAS protein, a molecular driver present in approximately 90% to 95% of pancreatic cancer cases. The approval follows results from the Phase III RASolute 302 trial, which showed that patients receiving Rasonque achieved a median overall survival of 13.2 months, compared to 6.7 months for those receiving standard chemotherapy. Clinical data also indicated a 60% reduction in the risk of death and an objective response rate of 30%. Global efforts to secure access continue. In Japan, patients and families have launched an online petition for “conditional early approval” of the drug, which has already been designated as an orphan drug by the Ministry of Health, Labour and Welfare. In Europe, the European Medicines Agency (EMA) recommended the approval of Rasonque for adults with metastatic pancreatic cancer who have undergone at least one prior treatment. This recommendation follows an accelerated assessment procedure. Following the EMA's positive opinion from On 18 October 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP), (CHMP) issued a positive opinion for didaraxonrasib, an oral therapy for adults with metastatic pancreatic adenocarcinoma who have previously undergone chemotherapy. Evaluated under the final decision regarding Cancer Medicines Pathfinder pilot program, the drug aims to address high unmet medical needs. Following this opinion, the medication must receive formal marketing authorization rests with from the European Commission. Once authorized, individual EU member states, Commission before national authorities, such as Italy, will determine Italy’s AIFA, can negotiate pricing and reimbursement. This follows previous tensions regarding costs, with AIFA estimating that treating 4,000 eligible patients in Italy would cost the state €1.6 billion.
Versions
- 2026-10-21 03:12 UTC FDA approves Rasonque; EMA recommends for pancreatic cancer
- 2026-10-19 03:12 UTC FDA approves Rasonque; EMA recommends for pancreatic cancer
- 2026-10-15 15:19 UTC FDA approves Rasonque for pancreatic cancer; EMA recommends
- 2026-10-01 23:42 UTC FDA approves Rasonque for pancreatic cancer; access disputes
- 2026-09-24 23:41 UTC FDA approves Rasonque for pancreatic cancer; lung cancer use
- 2026-09-23 09:26 UTC FDA approves Rasonque for pancreatic cancer; lung cancer use
- 2026-09-04 02:44 UTC FDA approves Rasonque for pancreatic cancer; lung cancer use
- 2026-08-31 07:55 UTC FDA approves Rasonque for advanced pancreatic cancer
- 2026-08-29 00:36 UTC FDA approves Rasonque for advanced pancreatic cancer
- 2026-08-28 21:05 UTC FDA approves Rasonque for advanced pancreatic cancer
- 2026-08-28 19:50 UTC FDA approves Rasonque for advanced pancreatic cancer
- 2026-08-28 10:18 UTC FDA approves Rasonque for advanced pancreatic cancer
- 2026-08-27 19:54 UTC FDA grants expedited approval for daraxonrasib
- 2026-08-26 17:27 UTC FDA grants expedited approval for daraxonrasib
- 2026-08-14 20:15 UTC Daraxonrasib trial shows doubled survival, EMA review on-go
- 2026-08-01 01:01 UTC Daraxonrasib trial shows doubled survival, EMA review ongo‑g
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