News
CHMP recommends Gavreto to treat RET fusion-positive advanced non small lung cancer.
Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
The CHMP recommendation is based on the results of the phase I/II ARROW study, in which Gavreto demonstrated rapid, potent, and durable clinical activity in patients with advanced RET fusion-positive NSCLC. A final decision regarding the approval of Gavreto is expected from the European Commission in the coming months.
Condition: NSCLC/ RET KInase
Type: drug