Pfizer files for FDA approval of lorlatinib

As of February 12, 2018

Pfizer filed a new drug application (NDA) for lorlatinib with the FDA, Japan, and Europe for use in patients with ALK-positive lung cancer. FDA’s decision is expected by the end of August.

In support of the 3 applications, Pfizer submitted data from the phase II part of a phase I/II trial in which the overall response rate (ORR) was 69% inĀ ALK-positive patients previously treated with crizotinib (Xalkori) with or without chemotherapy, and the Intracranial ORR was 68%. See previous posts for more detail.

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