The U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials –  expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

Rick Pazdur, director of the U.S. Food and Drug Administration’s Oncology Center of Excellence and longtime defender of the agency’s accelerated approval program, acknowledged that some changes are likely needed to the process to ensure timely receipt of confirmatory trial data.

The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

The U.S. Food and Drug Administration approved Seattle Genetics’ Tukysa (tucatinib) in combination with chemotherapy agents trastuzumab and capecitabine for adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body.

The U.S. Food and Drug Administration granted approval to Seattle Genetics Inc.’s Tukysa tablets in combination with trastuzumab and capecitabine for 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.