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Pfizer Receives Positive CHMP Opinion for Lorviqua for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer.

M2 PHARMA-March 4, 2019-Pfizer Receives Positive CHMP Opinion for Lorviqua for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer

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- The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for Lorviqua (lorlatinib, approved in the US, Canada, and Japan under the brand name Lorbrena), an anaplastic lymphoma kinase tyrosine kinase inhibitor, US-based pharmaceutical company Pfizer (NYSE: PFE) said.

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, with a decision expected in the coming months.

The Marketing Authorization Application for Lorviqua was based on results from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multi-centre Phase 1/2 study, B7461001, evaluating Lorviqua for the treatment of patients with ALK-positive advanced NSCLC, who were previously treated with one or more ALK TKIs.

A total of 229 patients with ALK-positive metastatic NSCLC were enrolled across various subgroups based on prior treatment.

Lorviqua is a TKI that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK. Lorviqua was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.

Lorviqua is approved in the US under the brand name Lorbrena for the treatment of patients with anaplastic lymphoma kinase -positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease, or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

This indication is approved under accelerated approval based on tumor response rate and duration of response.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. It is also approved in Japan and Canada.

Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12 healthy subjects receiving a single dose of LORBRENA with multiple daily doses of rifampin, a strong CYP3A inducer.

Grade 4 ALT or AST elevations occurred in 50% of subjects, Grade 3 in 33% of subjects, and Grade 2 in 8% of subjects.

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Publication:M2 Pharma
Date:Mar 4, 2019
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