publication date: Feb. 7, 2020

Drugs & Targets

EMA accepts tucatinib application in HER2-positive breast cancer

European Medicines Agency accepted the Marketing Authorization Application for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.

Tucatinib is sponsored by Seattle Genetics.

The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.

The MAA is based on data from the HER2CLIMB clinical trial, which compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. Patients had previously received trastuzumab, pertuzumab and ado-trastuzumab emtansine.

Patients had received a median of four prior lines of therapy overall and three in the metastatic setting. Forty-seven percent of the patients enrolled in the trial had brain metastases at the time of enrollment.

The New Drug Application for tucatinib was submitted to FDA Dec. 23, 2019, under the Real-Time Oncology Review Pilot Program. The review of the tucatinib NDA is also being conducted under Project Orbis, an initiative of FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among participating international partners.

Tucatinib was recently granted Breakthrough Therapy designation by FDA in combination with trastuzumab and capecitabine, for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have … Continue reading EMA accepts tucatinib application in HER2-positive breast cancer

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