Pfizer’s lorlatinib has been designated a Promising Innovative Medicine for the treatment of some patients with ALK-positive advanced non-small cell lung cancer.
The drug is currently under review by the European Medicines Agency for patients with the condition who have previously been treated with a second generation ALK tyrosine kinase inhibitor (TKI).
The PIM award indicates that the regulator considers lorlatinib a promising candidate for the UK’s Early Access to Medicines Scheme, which gives patients with life threatening or seriously debilitating conditions access to medicines before they are approved for use in Europe.
In the second stage of the process, the Agency will issue an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value, paving the way for patient access, opening up access before a regulatory decision is reached.
Lorlatinib is an investigational next-generation ALK/ROS1 tyrosine kinase inhibitor shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of both ALK and ROS1.
About 87 out of 100 lung cancers in the UK (87 percent) are non-small cell lung cancer, of which around 460 are advanced ALK-positive.