European regulators have awarded Ignyta’s cancer drug entrectinib Priority Medicines (PRIME) designation, potentially placing the treatment on a faster path to approval.
Igynta is developing entrectinib – an investigational, orally available, CNS-active tyrosine kinase inhibitor – for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in patients who have either progressed following prior therapies or who have no acceptable standard therapy.
The European Medicines Agency introduced its PRIME programme to expedite the regulatory process for investigational medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
Through the initiative, Ignyta will have enhanced support from the regulator, including optimising the entrectinib development pathway, potentially accelerating assessment of the marketing application, and engaging in early discussion with both the EMA and health technology assessments regarding reimbursement pathways.
The designation “further validates the broad potential of entrectinib as a novel treatment for patients, regardless of age, with NTRK-positive tumours, a group of cancers for which there currently is no approved treatment,” said Jonathan Lim, chairman and chief executive of Ignyta.
“We look forward to collaborating with the EMA, as well as other global regulatory authorities, on the accelerated assessment of entrectinib with the goal to provide a new therapy for patients in need.”
The drug was awarded breakthrough status in the US back in May.
