Cascadian Therapeutics Reports Positive Regulatory Reception At European Medicines Agency

Cascadian Therapeutics Tuesday reported that, after discussions with the European Medicines Agency (EMA) regarding tucatinib, a treatment of HER2-positive metastatic breast cancer, it received confirmation that positive results from its ongoing pivotal trial of tucatinib could serve as a single registrational trial for submission of a Marketing Authorization Application to the EMA and potential approval.

Cascadian reported it received similar confirmation from the U.S. Food and Drug Administration in 2016. The company said, “Our interactions with regulators in the U.S. and Europe continue to support the design of our pivotal trial as a registrational pathway for tucatinib in both regions.”

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