Pfizer has received marketing authorisation for its drug Lorviqua (lorlarinib) from the European Commission (EC).
The drug is a monotherapy for treatment of adults diagnosed with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC), who have no received prior treatment with an ALK inhibitor.
Lorviqua – marketed under the brand name Lorbrena – is approved in the US by the Food and Drug Administration (FDA). Adults who received this drug have been diagnosed with metastatic NSCLC whose tumours are ALK-positive as confirmed by an FDA-approved test. These are patients whose disease has progressed after receiving alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.
The EC approval for the first-line treatment using Lorviqua was based on crucial results from the phase 3 CROWN trial. Compared to Xalkori (crizotinib), the drug was shown to reduce the risk of disease progression or death by 72%.
The CROWN trial is a randomised, open-label parallel two-part trial. It included 296 people with previously untreated advanced ALK-positive NSCLC who were split equally into two random groups. The first group received Lorviqua monotherapy and the second group received Xalkori monotherapy.
Andy Schmeltz, global president and general manager of Pfizer Oncology, said: “The European Commission’s approval of Lorviqua as a first-line therapy is a significant milestone that we hope will help bring a needed and meaningful difference to those impacted by this deadly disease in Europe.”
Professor Benjamin Solomon, Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, said: “The expanded approval for Lorviqua in Europe is a considerable advancement – especially for the close to 40% of patients with ALK-positive metastatic NSCLC who are faced with brain metastases at diagnosis.”
Solomon added: “It is exciting to see the significant data generated from the CROWN trial continuing to support expanded use around the world and providing physicians in Europe with a highly effective option from the onset of their patients’ treatment journey.”
In 2019, the drug was given conditional marketing authorisation for Lorviqua as a monotherapy for the treatment of adults with ALK-positive advanced NSCLC by the EC.
Lorviqua’s safety profile is similar to data reported in earlier studies and detailed results from the CROWN trial were published in the New England Journal of Medicine in November 2020.