FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.
As part of a sweep of leadership changes at FDA, Heidi Overton, deputy director of the White House Domestic Policy Council, has been nominated to the role of FDA commissioner.
