EAMS possible for Pfizer’s lorlatinib

Pfizer’s lorlatinib is an investigational ALK/ROS1 tyrosine kinase inhibitor highly active in preclinical lung cancer models with chromosomal rearrangements of both ALK and ROS1. Patients with ALK-positive metastatic non-small cell lung cancer have a high risk of disease progression, often to the brain, so lorlatinib was designed to inhibit tumour mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.
The EMA are assessing lorlatinib for patients previously treated with a second generation ALK tyrosine kinase inhibitor (TKI). It has been given a Promising Innovative Medicine award for the treatment of some patients with ALK-positive advanced non-small cell lung cancer, which suggests the EMA thinks the drug is suitable for the UK’s Early Access to Medicines Scheme. This scheme allows certain patients access to medicines before they are approved for use in Europe, especially in the case of life threatening conditions, when there is a clear unmet medical need.
Clinical trials in patients with ALK-positive or ROS1-positive advanced non-small cell lung cancer are underway to assess safety and tolerability of single-agent lorlatinib at increasing dose levels. If the data supports clinical value and positive benefits, the EMA will issue an EAMS Scientific Opinion, providing access to this drug prior to market authorisation.