FDA approves Pfizer's dacomitinib for first-line NSCLC
FDA approved Vizimpro dacomitinib from Pfizer Inc. (NYSE:PFE) as first-line treatment of EGFR-mutated metastatic non-small cell lung cancer. Pfizer spokesperson Jessica Smith told BioCentury the pharma will launch the drug in mid-October at a monthly wholesale acquisition cost (WAC) of $12,400.
Vizimpro is approved in patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. The agency reviewed the NDA under Priority Review. The EGFR, EGFR2 and EGFR4 inhibitor is under EMA review for the same indication...