FDA and CTTI announced a call for applications for new members of the Patient Engagement Collaborative. The PEC is an ongoing, shared forum in which the patient community (PEC members), FDA, and CTTI discuss a variety of topics such as improving communication, education, and patient engagement related to medical product regulation.
FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
