Genentech’s Gavreto scores US approval for RET thyroid cancer
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.
Read more: http://www.pharmatimes.com/news/genentechs_gavreto_scores_us_approval_for_ret_thyroid_cancer_1359022
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.
Read more: http://www.pharmatimes.com/news/genentechs_gavreto_scores_us_approval_for_ret_thyroid_cancer_1359022