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EU Okays Pfizer's Lorviqua As First-Line Treatment For ALK-Positive Advanced Lung Cancer

Pfizer Inc. (PFE) said Friday that the European Commission granted marketing authorization for Lorviqua or lorlatinib as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase or ALK- positive advanced non-small cell lung cancer or NSCLC previously not treated with an ALK inhibitor.

The approval was based on results from Phase 3 CROWN trial, showing Lorviqua reduced risk of disease progression or death by 72% in newly diagnosed individuals compared to XALKORI (crizotinib).

The European Commission approval of Lorviqua follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Lorviqua is approved in the U.S. by the Food and Drug Administration under the brand name LORBRENA for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

In 2019, the European Commission granted conditional marketing authorization for Lorviqua as a monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.

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