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FDA grants breakthrough therapy designation to lorlatinib for ALK–positive NSCLC
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The FDA granted breakthrough therapy designation to lorlatinib for the treatment of patients with anaplastic lymphoma kinase–positive metastatic non–small cell lung cancer, according to the drug’s manufacturer.
Lorlatinib (PF-06463922, Pfizer) is an investigational next-generation ALK/ROS1 tyrosine kinase inhibitor. The designation is intended for patients who have been previously treated with one or more ALK inhibitors.
The decision was supported by the phase 1/phase 2 trial of lorlatinib, designed to evaluate the drug’s safety and efficacy in patients with ALK–positive NSCLC who were previously treated with one or more ALK inhibitors.
“This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK–positive NSCLC whose cancers have progressed despite treatment. Pfizer’s rapid development of lorlatinib reflects a commitment to developing biomarker-driven therapies to meet the evolving needs of patients,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer Global Product Development, said in a company-issued release. “We look forward to working with the FDA to accelerate the development of this therapy.”
In addition, the open-label, randomized, two-arm phase 3 CROWN study — designed to compare lorlatinib with crizotinib (Xalkori, Pfizer) in the first-line treatment of patients with metastatic ALK–positive NSCLC — is ongoing.