First-Line Lorlatinib Receives Approval From the European Commission for ALK+ Advanced NSCLC

The European Commission approves the use of lorlatinib for the treatment of ALK-positive advanced non–small cell lung cancer.

Lorlatinib (Lorviqua) was approved by the European Commission as a first-line treatment for patients with ALK-positive advanced non–small cell lung cancer (NSCLC), according to a press release from developer Pfizer.1

The regulatory decision was based on findings from the phase 3 CROWN trial, with key data including a 72% reduction in risk of disease progression or death vs crizotinib (Xalkori). Moreover, lorlatinib resulted in an overall response rate of 76% (95% CI, 68%-83%) compared with 58% (95% CI, 49%-66%) among those treated with crizotinib. In a cohort of patients with brain metastases, investigators reported an intracranial response rate of 82% and 23% in the lorlatinib and crizotinib arms, respectively.

“For more than a decade, Pfizer has worked tirelessly in its pursuit to help transform the trajectory for people living with advanced, biomarker-driven lung cancers,” Andy Schmeltz, global president & general manager at Pfizer Oncology, said in a press release. “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.”

Lorlatinib received approval by the FDA in March 2021 for patients with ALK-positive NSCLC that was detected via an FDA-approved test.2


  1. European Commission approves LORVIQUA® (lorlatinib) as a first-line treatment for ALK-positive advanced lung cancer. News release. Pfizer. January 28, 2022. Accessed January 31, 2022.
  2. U.S. FDA expands approval of Pfizer’s Lorbrena as first-line treatment for ALK-positive metastatic lung cancer. News release. Pfizer. March 3, 2021. Accessed January 31, 2022.