Shots:

• The approval is based on P-I/II ARROW study assessing Gavreto (400mg- qd) in RET fusion-positive NSCLC patients with or without prior therapy- and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC- RET fusion-positive thyroid cancer- and other RET-altered solid tumors
• Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT- m-DOR was not reached- in 27 treatment-naïve NSCLC patients- ORR (70%); CR rate (11%). Gavreto is now the 6^th FDA-approved medicine in Genentech's portfolio for lung cancer and will co-commercialize by Genentech and Blueprint Medicines in the US
• Gavreto is an oral precision therapy targeting RET alterations- including fusions and mutations- regardless of the tissue of origin. Additionally- the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR designation for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb- 2021

­ Ref: Roche | Image: Trial Site News