Pfizer's Lorbrena Wins Full FDA Approval As First Line Treatment Of ALK-Positive Lung Cancer

The FDA has approved Pfizer Inc's (NYSE: PFE) supplemental application seeking approval for Lorbrena (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

• The FDA action also converts 2018 accelerated approval to full approval.
• In 2018 Lorbrena was approved for patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy.
• The approval is based on the CROWN trial, which showed a 72% reduction in risk of progression or death for treatment with Lorbrena vs. Xalkori, recognized as the first-line standard of care for patients with ALK-positive advanced NSCLC.
• Price Action: PFE shares are down 0.4% at $34.25 in premarket trading on the last check Thursday.