Genentech’ Gavreto (pralsetinib) Receives the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

 Genentech’ Gavreto (pralsetinib) Receives the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Genentech’ Gavreto (pralsetinib) Receives the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

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 6th 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

Click here ­to­ read full press release/ article | Ref: Roche | Image: Trial Site News

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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