FDA has approved Hyrnuo (sevabertinib), an oral, reversible, tyrosine kinase inhibitor, for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
Rick Pazdur, MD, the newly appointed director for the Center for Drug Evaluation and Research at the FDA, has been described as “greyhound thin” as a result of his dedication to cycling and lifting weights in the gym each day and, for a long time, a vegetarian diet. I first met him when he was the director of the Office of Oncology Drug Products (ODP) within CDER, in 2009.
