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“While these findings cannot be exploited to improve clinical decision making today, our results, and the underlying data, collected on an increasingly rare group of triple-negative breast cancer patients treated with locoregional therapy alone, are a valuable contribution to ongoing research on the development, progression and ultimate treatment of triple-negative breast cancer."

The FDA granted accelerated approval for tucatinib tablets in combination with trastuzumab and capecitabine as treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases who have received one or more prior anti-HER2-based regimens in the metastatic setting. The approval comes 4 months ahead of the targeted action date from the FDA’s Real-Time Oncology Review.

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

A statistically significant improvement in the total pathologic complete response rate, the primary end point of the study, was observed with neoadjuvant treatment of pertuzumab, trastuzumab and docetaxel compared with placebo, trastuzumab, and docetaxel in Asian patients with&nbsp;<a><em>ERBB2</em></a>&nbsp;-positive early or locally advanced breast cancer, according to the phase III PEONY trial.