Cascadian Therapeutics received a pediatric waiver from the European Medicines Agency (EMA) for their lead candidate tucatinib, currently in a trial treating HER2+ metastatic breast cancer.
Cascadian Therapeutics (NASDAQ:CASC) received a pediatric waiver from the European Medicines Agency (EMA) for their lead candidate tucatinib, currently in a trial treating HER2+ metastatic breast cancer.
As quoted in the press release:
“This pediatric waiver is another important milestone in the European regulatory process, and will allow Cascadian to submit a marketing authorization application for tucatinib for the treatment of HER2+ metastatic breast cancer to the EMA following completion of the HER2CLIMB pivotal trial, without the requirement to conduct clinical studies in the pediatric population prior to approval or post-approval,” said Scott D. Myers, President and Chief Executive Officer of Cascadian Therapeutics.
As part of the regulatory process for the registration of new medicines with the EMA, pharmaceutical companies are required to have in place an approved Pediatric Investigation Plan (PIP) prior to MAA filing that outlines the clinical development strategy for studying the investigational product in the pediatric population. In some instances, a waiver from required pediatric studies for certain conditions may be granted by the EMA when development of a medicine for use in children is not feasible or appropriate.