On June 29, 2016 Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that the ONT-380 program in advanced HER2+ metastatic breast cancer has received Fast Track designation from the U.S. Food and Drug Administration ("FDA") (Press release, Cascadian Therapeutics, JUN 29, 2016, View Source [SID:1234513600]).

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The Company is actively recruiting patients for a randomized, double-blind, placebo-controlled Phase 2 study, known as HER2CLIMB, evaluating ONT-380 in combination with trastuzumab and capecitabine for patients with advanced HER2+ metastatic breast cancer. This trial is expected to enroll up to 180 patients with and without brain metastases. ONT-380 is an oral, highly selective small molecule inhibitor of HER2.

"Fast Track designation recognizes the unmet medical need for this serious disease," said Scott Myers, President and CEO of Cascadian Therapeutics. "Many patients with metastatic HER2+ breast cancer will see their disease progress despite the availability and use of multiple targeted therapies. We are encouraged by the early evidence of systemic activity and activity against brain metastases, and the favorable tolerability profile with ONT-380 in combination studies."

The FDA established the Fast Track designation process to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Through the Fast Track program, more frequent meetings may be scheduled with the FDA to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Additionally, the drug may qualify for accelerated approval and priority review and, at the time of a new drug application (NDA) filing, the drug candidate’s sponsor may be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted.

"Fast Track designation has the potential to reduce development time and cost associated with bringing a drug to patients," said Valerie Fauvelle, Director of Regulatory Affairs for Cascadian Therapeutics. "We look forward to working closely with the FDA to rapidly advance ONT-380 through the clinical development and regulatory process."

On June 29, 2016 Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported that the ONT-380 program in advanced HER2+ metastatic breast cancer has received Fast Track designation from the U.S. Food and Drug Administration (“FDA”) (Press release, Cascadian Therapeutics, JUN 29, 2016, View Source [SID:1234513600]).

The Company is actively recruiting patients for a randomized, double-blind, placebo-controlled Phase 2 study, known as HER2CLIMB, evaluating ONT-380 in combination with trastuzumab and capecitabine for patients with advanced HER2+ metastatic breast cancer. This trial is expected to enroll up to 180 patients with and without brain metastases. ONT-380 is an oral, highly selective small molecule inhibitor of HER2.

“Fast Track designation recognizes the unmet medical need for this serious disease,” said Scott Myers, President and CEO of Cascadian Therapeutics. “Many patients with metastatic HER2+ breast cancer will see their disease progress despite the availability and use of multiple targeted therapies. We are encouraged by the early evidence of systemic activity and activity against brain metastases, and the favorable tolerability profile with ONT-380 in combination studies.”

The FDA established the Fast Track designation process to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Through the Fast Track program, more frequent meetings may be scheduled with the FDA to discuss the drug’s development plan and to ensure the collection of appropriate data needed to support approval. Additionally, the drug may qualify for accelerated approval and priority review and, at the time of a new drug application (NDA) filing, the drug candidate’s sponsor may be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted.

“Fast Track designation has the potential to reduce development time and cost associated with bringing a drug to patients,” said Valerie Fauvelle, Director of Regulatory Affairs for Cascadian Therapeutics. “We look forward to working closely with the FDA to rapidly advance ONT-380 through the clinical development and regulatory process.”