Breakthrough Therapy Designation for Pfizer’s ALK/ROS1 inhibitor

Pfizer today announced that its ALK/ROS1 small molecule tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the FDA for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer. In 2015 lorlatinib was already granted orphan drug status.

 “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,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “We look forward to working with the FDA to accelerate the development of this therapy.”

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