February FDA approvals include second CNPV

Hernexeos zongertinib became the second drug to receive an expedited review by FDA under the new commissioner’s national priority voucher program, gaining accelerated approval for first-line lung cancer with HER2 tyrosine kinase domain activating mutations on Feb. 26. 

The small molecule HER2 inhibitor from Boehringer Ingelheim GmbH already had accelerated approval for later lines of therapy. FDA said it filed the application on Jan. 13, bringing the review to 44 days...