EMA CHMP 对 Revolution Medicines 的 daraxonrasib（Rasonque）给出积极意见
Human medicines European public assessment report (EPAR): Rasonque, Daraxonrasib, Status: Opinion
2026 年 10 月 15 日，EMA 人用药品委员会（CHMP）通过积极意见，建议批准 Rasonque（daraxonrasib）单药用于已接受至少一种既往系统治疗的成人转移性胰腺腺癌患者。
CHMP 对 daraxonrasib 给出积极意见，读者可了解这款 RAS 抑制剂在转移性胰腺癌中的适用人群与主要疗效终点。
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.
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
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
来源：EMA New Medicine · ema.europa.eu