FDA grants priority review to Lorbrena for lung cancer subset
The FDA granted priority review to lorlatinib for first-line treatment of anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, according to the agent’s manufacturer.
Lorlatinib (Lorbrena, Pfizer) is a third-generation anaplastic lymphoma kinase (ALK) inhibitor designed to inhibit tumor mutations that most often contribute to treatment resistance. It also is designed to address brain metastases.
Approximately 3% to 5% of patients with NSCLC harbor ALK mutations, representing an estimated 13,000 new cases in the United States each year. About 40% of patients with ALK-positive NSCLC develop brain metastases.
The FDA previously approved lorlatinib for treatment of certain patients with ALK-positive metastatic NSCLC whose disease progressed after treatment.
The agency based the priority review for the first-line indication on results of the randomized phase 3 CROWN trial, which included 296 patients with previously untreated ALK-positive NSCLC.
Researchers randomly assigned 149 patients to lorlatinib monotherapy. The other 147 patients received crizotinib (Xalkori; Pfizer, EMD Serono), an ALK tyrosine kinase inhibitor.
PFS based on blinded independent central review served as the primary endpoint. Secondary endpoints included investigator-assessed PFS, as well as OS, objective response rate, intracranial response and safety.
As Healio previously reported, the trial met its primary endpoint.
The FDA will evaluate the lorlatinib application through its Real-Time Oncology Review Pilot Program — designed to accelerate the delivery of effective and safe cancer treatments to patients — and Project Orbis, which provides a framework for concurrent submission and review of oncology drug applications among international agencies.
The agency is expected to make a decision on approval by April.
“The decision by the FDA to evaluate our application for Lorbrena under its innovative review pathways, which aim to speed up availability of potentially life-changing medicines, underscores the significance of the CROWN data and potential impact of Lorbrena as an initial therapy for people with ALK-positive advanced non-small cell lung cancer,” Chris Boshoff, MD, PhD, chief development officer for oncology with Pfizer Global Product Development, said in a company-issued press release. “We look forward to working with the FDA to bring this treatment option to patients as quickly as possible.”