Mobocertinib (TAK-788) has received FDA Priority Review for the treatment of adult patients with epidermal growth factor receptor Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer, as detected by an FDA-approved test, who have received prior platinum-based chemotherapy.
The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
