Lorlatinib, a tyrosine kinase inhibitor, has been granted breakthrough therapy designation by the FDA for the treatment of some patients with non-small cell lung cancer (NSCLC), reports Healio.
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.”
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