4 September 2020 - Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers.

Genentech today announced that the U.S. FDA has approved Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test. 

This indication was approved under the FDA’s accelerated approval program based on data from the Phase I/II ARROW trial.

The FDA has also granted priority review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, and is expected to make a decision on approval by 28 February 2021. This new drug application was accepted for review under the FDA’s Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.

Read Genentech press release