Pfizer Inc. (NYSE:FDA) reported that the U.S. Food and Drug Administration has accepted Priority Review for the supplemental New Drug Application for LORBRENA in previously untreated ALK-positive lung cancer.
LORBRENA is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases.
“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 Chief Development Officer Chris Boshoff.
“We look forward to working with the FDA to bring this treatment option to patients as quickly as possible.”
The FDA also will conduct the review under Project ORBIS, an initiative introduced in 2019, which provides a framework for potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom. Under Project ORBIS, collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries. 5
In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
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