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U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

(Pfizer) Mar 3, 2021 - The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s supplemental New Drug Application (sNDA) for LORBRENA® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. The FDA action also converts the 2018 accelerated approval to full approval. The application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program.

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H. Jack West, MD (Posted: March 05, 2021)

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Lorlatinib is an excellent ALK inhibitor, but beating crizotinib as first line therapy for patients with ALK-positive advanced NSCLC only puts it on par with alectinib as a current standard of care or other 2nd generation ALK inhibitors also superior to crizotinib and approved in this setting. Lorlatinib has good activity, both extracranial and intracranial, but its toxicity profile is somewhat idiosyncratic, particularly the neuro-behavioral issues. I do not think it emerges as offering a clear incremental benefit over alectinib. Moreover, using lorlatinib first line means that it isn't available as second line therapy, where it is arguably the leading option after progression on alectinib or another ALK inhibitor.

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