The FDA granted a priority review to the supplemental new drug application for Lorbrena for the firstline treatment of ALK-positive metastatic non-small cell lung cancer.
The Food and Drug Administration (FDA) recently granted priority review to the supplemental new drug application for Lorbrena (lorlatinib) for the firstline treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), according to the agent’s manufacturer, Pfizer.
“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,” said Dr. Chris Boshoff, chief development officer of oncology at Pfizer Global Product Development. “We look forward to working with the FDA to bring this treatment option to patients as quickly as possible.”
The filing was based on results from the randomized, open-label, phase 3 CROWN trial, in which Lorbrena significantly improved progression-free survival (or time of treatment until disease progression) versus Xalkori (crizotinib) in patients with previously untreated ALK-positive NSCLC.
Lorbrena is currently approved for the treatment of patients with ALK-positive NSCLC whose disease has progressed after receiving treatment with Xalkori and at least one ALK tyrosine kinase inhibitor, or whose disease progressed after receiving Alecensa (alectinib) or Zykadia (ceritinib).
The agency is set to make its decision on whether to approve the therapy by April 2021.
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