California-based biotech company Revolution Medicines has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has initiated a phased review of data for daraxonrasib, the company’s investigational RAS(ON) multi-selective inhibitor being developed for pancreatic cancer.
The phased review process is designed to accelerate the evaluation of promising medicines by allowing regulators to assess clinical data in phases as they become available, ahead of the submission of a full marketing authorization application.
Daraxonrasib has already received orphan medicinal product designation from the EMA for the treatment of pancreatic cancer and has been recognized as a high-priority candidate under the agency’s Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need.
The regulatory milestone in Europe comes as Revolution Medicines advances its rolling New Drug Application (NDA) submission for daraxonrasib to the US Food and Drug Administration under the FDA Commissioner’s National Priority Voucher pilot programme, which aims to expedite the development and review of therapies addressing US national health priorities.
Mark A. Goldsmith, chief executive officer and chairman of Revolution Medicines, said, “The EMA’s decision to include daraxonrasib in its new phased review process is an important step toward making this medicine available to patients globally as quickly as possible.”
The company said it is also engaging with regulatory authorities in other regions as it prepares additional marketing submissions.
The ongoing regulatory reviews are supported by positive findings from the pivotal Phase 3 RASolute 302 trial. The study demonstrated significant improvements in overall survival and progression-free survival compared with standard cytotoxic chemotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), regardless of whether a tumour RAS mutation had been identified. Daraxonrasib also showed a manageable safety profile and delayed deterioration in cancer-related pain, overall health status, and quality of life compared with chemotherapy.
Daraxonrasib: How it works
Daraxonrasib is an investigational oral, non-covalent RAS(ON) multi-selective tri-complex inhibitor designed to target a broad spectrum of RAS-driven cancers. In addition to pancreatic cancer, the therapy is being evaluated in non-small cell lung cancer (NSCLC) and colorectal cancer.
It works by suppressing RAS signalling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.
The investigational therapy has previously received both Breakthrough Therapy Designation and Orphan Drug Designation from the US FDA for the treatment of patients with previously treated metastatic PDAC harbouring G12 mutations. It was also selected for the FDA Commissioner’s National Priority Voucher pilot programme.
Revolution Medicines is advancing daraxonrasib through a global Phase 3 development programme comprising four registrational studies, including the completed RASolute 302 trial and three ongoing trials in patients with PDAC and metastatic RAS-mutant NSCLC.
Pancreatic ductal adenocarcinoma is the most common form of pancreatic cancer and remains one of the deadliest malignancies, with nearly 80% of patients diagnosed at an advanced or metastatic stage. More than 90% of PDAC tumours harbour RAS mutations, making the disease one of the most RAS-driven cancers.
