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CHMP opinion positive for Lorviqua as first-line treatment for ALK-positive advanced NSCLC.- Pfizer Inc.

Read time: 1 mins
Last updated:20th Dec 2021
Published:19th Dec 2021
Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Lorviqua (lorlatinib, available in the U.S. under the brand name Lorbrena), for marketing authorization as a first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

The CHMP’s opinion will now be verified by the European Commission (EC) with a decision expected in the coming months. The application for the first-line use of Lorviqua was based on the results of the pivotal Phase III CROWN trial, in which Lorviqua reduced the risk of disease progression or death by 72% compared to Xalkori(crizotinib). In patients with measurable brain metastases, 82% of patients in the Lorviqua arm experienced an intracranial response (71% experiencing an intracranial complete response), compared to 23% of Xalkori patients.

Condition: NSCLC/ ALK+
Type: drug

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