Pfizer's Third-Generation ALK Inhibitor Lorlatinib Receives NMPA Acceptance for Marketing Application in China

On April 15, information from the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) indicated that the marketing application for lorlatinib, Pfizer’s third-generation ALK inhibitor, had been accepted.

It is reported that the drug has previously been approved for marketing in Hong Kong, China, for the treatment of patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed after prior ALK inhibitor therapy.

Lorlatinib is a tyrosine kinase inhibitor (TKI) that has demonstrated high activity in preclinical lung cancer models harboring ALK rearrangements. Lorlatinib was specifically developed to inhibit ALK gene mutations resistant to other ALK inhibitors and can cross the blood-brain barrier to treat brain metastases. In November 2018, the U.S. FDA granted accelerated approval for the drug to treat patients with ALK-positive metastatic NSCLC whose disease progressed after treatment with crizotinib and at least one other ALK inhibitor, or after treatment with alectinib or ceritinib as the first-line ALK inhibitor therapy. On the 5th of last month, the U.S. FDA approved an expanded indication for lorlatinib for the first-line treatment of patients with ALK-positive NSCLC.