Rasonque

Opinion

EMA has issued an opinion on this medicine

Daraxonrasib

Overview

On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Rasonque,intended as monotherapy for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. 

The applicant for this medicinal product is Revolution Medicines Netherlands B.V.

Rasonque will be available as 100 mg and 150 mg film-coated tablets. The active substance of Rasonque is daraxonrasib, an antineoplastic agent (ATC code: not yet assigned) that inhibits the RAS GTPase family. Daraxonrasib binds to cyclophilin A to form a complex that inhibits RAS signalling by disrupting interactions with downstream effectors, thereby killing cancer cells and slowing cancer growth.

The benefits of Rasonque include longer median overall survival (OS) and median progression-free survival (PFS) compared with standard chemotherapy. The most common side effects are rash, diarrhoea, stomatitis, nausea and vomiting.

The full indication is:

Rasonque as monotherapy is indicated for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.

Rasonque should be initiated by physicians experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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Note: This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Rasonque

Adopted Reference Number: EMADOC-1829012207-72049

Product details

• Name of medicine:
  Rasonque
• Active substance:
  daraxonrasib
• International non-proprietary name (INN) or common name:
  Daraxonrasib
• Therapeutic area (MeSH):
  Pancreatic Neoplasms
• Anatomical therapeutic chemical (ATC) code:
  L01XX
• EMA product number:
  EMEA/H/C/007122
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Revolution Medicines Netherlands B.V.
• Opinion adopted:
  15/10/2026
• Opinion status:
  Positive