4th December 2020

Roche’s Genentech division and its partner Blueprint Medicines have scored a new approval for Gavreto in the US for the treatment of RET-altered thyroid cancer.

The US Food and Drug Administration (FDA) has cleared Gavreto (pralsetinib) for the treatment of adult and paediatric patients with advanced or metastatic RET-mutant and RET fusion-positive thyroid cancer.

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.

This newest approval is based on results from the phase I/II ARROW study, in which treatment with Gavreto led to an overall response rate (ORR) of 60% in 55 people with previously-treated RET-mutant metastatic medullary thyroid cancer (MTC).

In addition, Gavreto treatment led to an ORR of 66% in 29 people with RET-mutant advanced MTC who had not been previously treated with cabozantinib and vandetanib.

Around 10-20% of people with papillary thyroid cancer have RET-fusion positive tumours, with approximately 90% of people with MTC, which is a rare form of thyroid cancer, carry RET mutations.

“We are proud to partner with Blueprint Medicines to bring this important new option to people with certain types of RET-altered thyroid cancer,” said Levi Garraway, chief medical officer and head of Global Product Development at Roche.

“Gavreto is now approved across multiple RET-altered tumour types, underscoring our commitment to advancing personalised healthcare with treatments that target the underlying biology of each person’s cancer,” he added.

Back in September, Gavreto was cleared for use in the US for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).

This approval was also based on results from the phase I/II ARROW study, wherein Gavreto produced “durable clinical responses” in people with RET fusion-positive NSCLC with or without prior therapy, and regardless of RET fusion partner or central nervous system involvement.

From：http://www.pharmatimes.com/news/genentechs_gavreto_scores_us_approval_for_ret_thyroid_cancer_1359022