Cascadian Therapeutics (NASDAQ: CASC) this morning reported a positive outcome from recent discussions with the European Medicines Agency (EMA) regarding the development of the company’s investigational medicine for the treatment of HER2-positive metastatic breast cancer, tucatinib. The company has received validating news that if the ongoing pivotal trial of tucatinib known as HER2CLIMB demonstrates positive results, it could serve as a single registrational trial for submission of a Marketing Authorization Application (MAA) to the EMA and potential marketing approval. Cascadian received a similar confirmation from the FDA last year. “This is an important milestone for the company. We had anticipated providing an update on our European regulatory strategy later this year; and we are pleased with this early feedback from the EMA that the current design of the global HER2CLIMB trial, if positive, could support approval and a potentially shorter path to the European market for tucatinib. Site and patient enrollment is currently ahead of schedule in North America, and we are now poised to begin enrolling patients in HER2CLIMB in other countries,” Cascadian Therapeutics president and CEO Scott Myers stated in the news release.
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About Cascadian Therapeutics
Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. Its lead product candidate, tucatinib, is an investigational oral, selective small molecule HER2 inhibitor. Cascadian Therapeutics is conducting a randomized, double-blind controlled pivotal clinical trial called HER2CLIMB, which is comparing tucatinib vs. placebo, each in combination with capecitabine and trastuzumab, in patients with locally advanced or metastatic HER2-positive breast cancer with and without brain metastases, who have previously been treated with a taxane, trastuzumab, pertuzumab and T-DM1. For more information, please visit www.cascadianrx.com.
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