Posted by Michael Wonder on 18 Oct 2017
Ignyta receives European Medicines Agency Prime designation for entrectinib in NTRK fusion-positive solid tumours
17 October 2017 - Ignyta today announced that the EMA has granted Priority Medicines (PRIME) designation for entrectinib in the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy.
Through the PRIME initiative, Ignyta will have enhanced EMA support, including optimising the entrectinib development pathway, potentially accelerating assessment of the Marketing Authorisation Application, and engaging in early discussion with EMA and health technology assessments regarding reimbursement pathways.
PRIME designation for entrectinib was substantially based on data from the Phase 2 global study, STARTRK-2.
