Posted by Michael Wonder on 02 Mar 2019
Pfizer receives positive CHMP opinion for Lorviqua (lorlatinib) for certain adult patients with previously-treated ALK-positive advanced non-small cell lung cancer
1 March 2019 - Pfizer today announced that the CHMP of the 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 tyrosine kinase inhibitor.
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 whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy, or crizotinib and at least one other ALK tyrosine kinase inhibitor. 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, with a decision expected in the coming months.
