European Commission (EC) has granted marketing authorization for Lorviqua as monotherapy for treatment of patients with anaplastic lymphoma kinase (ALK) – positive advanced non-small cell lung cancer. Lorviqua is approved in US by Food and Drug Administration (FDA) under the brand name LORBRENA for treatment of patients with metastatic NSCLC whose tumors are ALK-positive. This EC approval has been followed by positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
This approval for first-line use of Lorviqua was based on the results of the pivotal phase 3 CROWN trial. In this trial, Lorviqua reduced the risk of disease progression or death by 72% in comparison with XALKORI. Also, the confirmed objective response rate was 76% with Lorviqua and 58% with XALKORI.
In this trial, the patients with measurable brain metastases, 82% of patients in Lorviqua arm experienced an intracranial response in comparison with 23% of XALKORI patients. This CROWN trial is open-label, parallel 2-arm trial and 296 people with previously untreated ALK-positive non-small cell lung cancer were randomized 1:1 to receive Lorviqua monotherapy or XALKORI monotherapy.
Professor Benjamin Solomon, MBBS, PhD., 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 percent of patients with ALK-positive metastatic NSCLC who are faced with brain metastases at diagnosis.” 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,” he added.
Pfizer’s Lorviqua has shown to be highly active in preclinical lung cancer models and has been developed to inhibit tumor mutations that drive resistance to other ALK inhibitors.
The information shared in this blog is for educational purposes only. You should consult your medical professional for any issues.