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"We are disappointed [with] this outcome. Breast cancer is a leading cause of death around the world and delaying or preventing the development of metastatic disease is a significant unmet need. PALLAS is a large study with many subgroups and we are actively collaborating to determine if there are patients who may benefit from adjuvant treatment with the palbociclib combination."

“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.