In March 2021, the FDA approved the use of Lorbrena (lorlatinib; from Pfizer), a third-generation ALK inhibitor, as first-line treatment of patients with non–small-cell lung cancer (NSCLC) and ALK mutation. Lorbrena was previously approved by the FDA as the second- or third-line treatment for patients with ALK-positive NSCLC, as detected by an FDA-approved test. This new indication also converts the previous accelerated approval to a full approval.
The expanded indication for Lorbrena was based on the results from the CROWN clinical trial, which compared Lorbrena and the first-generation ALK inhibitor Xalkori (crizotinib) in patients with metastatic NSCLC and ALK mutation who have not received any previous therapy.
The results showed a significant, 72% reduction in the risk of disease progression or death when using Lorbrena instead of Xalkori.
“The CROWN data have shown Lorbrena can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer, including those who present with brain metastases,” said Benjamin Solomon, MD, Department of Medical Oncology, Peter MacCallum Cancer Centre.
“This approval is meaningful for my patients, because we now have a highly effective treatment option that can delay the progression of a typically aggressive disease,” Dr. Solomon added.
The most common side effects with Lorbrena were edema, weight gain, peripheral neuropathy, cognitive side effects, diarrhea, difficulty breathing, and elevated triglyceride level. Treatment discontinuation because of side effects occurred in 6.7% of people.
