Pfizer: CHMP Nod for Previously-Treated Ling Cancer Med

Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for LORVIQUA^® (lorlatinib, approved in the U.S., Canada, and Japan under the brand name LORBRENA^®), an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). The CHMP has adopted a positive opinion recommending conditional marketing authorization for LORVIQUA as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy, or crizotinib and at least one other ALK TKI. Conversion to normal approval will be contingent on provisions of comprehensive data confirming that the benefit-risk balance is positive. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a decision expected in the coming months.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-Receives-Positive-CHMP-Opinion-for-LORVIQUA-lorlatinib-for-Certain-Adult-Patients-with-P-28093686/