Cancer drug Lorviqua granted 'Innovation Passport' from UK regulator

1 May 2021

A UK Innovation Passport has been granted for a proposed new indication in the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small-cell lung carcinoma (NSCLC), previously not treated with an ALK inhibitor for US pharma giant Pfizer’s (NYSE: PFE) Lorviqua (lorlatinib).

The Innovation Passport is the entry point to The Medicines and Healthcare products Regulatory Agency’s (MHRA) new Innovative Licensing and Access Pathway (ILAP), intended to offer regulatory support and flexibilities to bring new medicines to UK patients more quickly.

Lorlatinib is a third-generation ALK inhibitor, specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive NSCLC. Up to 40% of people with ALK-positive metastatic NSCLC present with brain metastases at initial diagnosis.

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