Research & Development
US Food and Drug Administration approves Pfizer's Lorbrena
6 November 2018 -

The US Food and Drug Administration (FDA) has approved United States-based Pfizer's Lorbrena (lorlatinib) for earlier -treated ALK-positive metastatic non-small cell lung cancer (NSLC), it was reported yesterday.

The product is a third-generation anaplastic lymphoma kinase tyrosine kinase inhibitor intended to treat patients with ALK-positive metastatic NSLC 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.

The product was approved based on results of a non-randomised, dose-ranging and activity-estimating, multi-cohort and multicentre phase 1/2 study.

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