FDA approves third-generation inhibitor for non-small cell lung cancer

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The FDA approved Pfizer’s Lorbrena, an orally ingestible tablet designed for the treatment of non-small cell lung cancer.

Lorbrena’s active ingredient is lorlatinib, which is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor in non-small cell lung cancer. The medication is to be used by patients who have experienced disease progression while on other ALK inhibitors such as ceritinib or alectinib.

“Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors,” Andy Schmeltz, global president, Pfizer Oncology, said in a press release. “We believe that Lorbrena will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”

Lorbrena is the third generation of ALK tyrosine kinase inhibitors from Pfizer, which introduced the first generation with Xalkori (crizotinib) in 2011.

A non-randomized study of 215 patients with ALK-positive metastatic non-small cell lung cancer was used to evaluate Lorbrena’s effect in treatment. Of the study population, 57% were treated with at least one other ALK-tyrosine kinase inhibitor prior to the study. Pfizer reported a response rate of 48% in the trial, with serious adverse reactions in 32% of patients.

“The last decade has witnessed dramatic improvements in the treatment of metastatic ALK-positive non-small cell lung cancer due to earlier generation ALK biomarker-driven therapies. Yet almost all patients still relapse due to drug resistance, with a large proportion of patients developing new or worsening brain metastases,” Alice T. Shaw, MD, PhD, professor of medicine at Harvard Medical School and director of the Center for Thoracic Cancers at Massachusetts General Hospital, said in the release. “In a clinical study which included patients with or without brain metastases, Lorbrena demonstrated clinical activity in patients with metastatic ALK-positive non-small cell lung cancer who had failed other ALK biomarker-driven therapies.”

Pfizer did note in its release that a confirmatory trial may determine the continued approval of Lorbrena.



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