Posted by Michael Wonder on 01 Jul 2020
Blueprint Medicines announces submission of new drug application to FDA for pralsetinib for the treatment of advanced RET mutant and RET fusion positive thyroid cancers
1 July 2020 - Blueprint Medicines today announced the submission of a new drug application to the U.S. FDA for pralsetinib for the treatment of patients with advanced or metastatic RET mutant medullary thyroid cancer and RET fusion-positive thyroid cancers.
Pralsetinib is an investigational, once-daily precision therapy designed to potently and selectively inhibit RET fusions and mutations, including predicted resistance mutations.
Blueprint Medicines submitted the application under the Real-Time Oncology Review pilot program, an initiative of the FDA's Oncology Center of Excellence.
