Pfizer’s new lung cancer drug accepted for regulatory review

Pfizer has announced that its new lung cancer drug lorlatinib has been accepted for regulatory review in a number of key territories.

The US Food and Drug Administration has accepted and granted priority review for the company's new drug application for the ALK tyrosine kinase inhibitor, with the European Medicines Agency and the Japan Pharmaceutical and Medical Devices Agency having also accepted marketing applications for the drug.

Lorlatinib is being developed for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have previously been treated with one or more drugs in this category, and could represent a potential breakthrough for these individuals.

Treatment resistance resulting in disease progression is a major challenge faced by patients with this form of NSCLC, which is why lorlatinib was developed by Pfizer with the specific goal of overcoming resistance to first and second-generation ALK-targeted therapies.

Dr Mace Rothenberg, chief development officer for oncology at Pfizer's global product development division, said: "The encouraging results observed in a variety of patients previously treated with ALK inhibitors provides the basis for these applications."

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