On November 2, 2018, Pfizer announced that the U.S. Food and Drug Administration (FDA) had approved lorlatinib, a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI), for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with crizotinib and at least one other ALK inhibitor for metastatic disease; or after treatment with alectinib or ceritinib as first-line ALK inhibitors for metastatic disease.
This indication received accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may depend on validation and description of clinical benefit in confirmatory trials. This is Pfizer's third oncology treatment approval within two months, including two lung cancer drugs.
Andy Schmelz, Global President of Pfizer Oncology, stated, “For many years, Pfizer has been transforming how we research, manage, and treat patients with ALK-positive non-small cell lung cancer. Based on our deep understanding of tumor complexity and treatment resistance, lorlatinib, discovered and developed by Pfizer scientists, is specifically designed to inhibit tumor mutations that can lead to resistance to other ALK tyrosine kinase inhibitors. We believe that lorlatinib will benefit patients with ALK-positive metastatic non-small cell lung cancer whose disease has progressed after previous treatments and will continue to fulfill our commitment to meeting the unmet needs of cancer patients.”
Since Pfizer launched Xalkori in 2011 as the first tyrosine kinase inhibitor for the treatment of ALK-positive metastatic non-small cell lung cancer, these drugs have provided patients with treatment options beyond chemotherapy. However, lung cancer remains the leading cause of cancer-related deaths worldwide.
About lorlatinib
Lorlatinib is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after treatment with crizotinib and at least one other ALK inhibitor for metastatic disease; or who have progressed after treatment with alectinib or ceritinib as first-line ALK inhibitors for metastatic disease.
