Lorbrena FDA approval : US pharma giant Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Lorbrena (lorlatinib) for anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC).
The FDA approval of Lorbrena is for the ALK-positive NSCLC patient population whose condition has progressed on treatment with alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
The Pfizer lung cancer drug has been approved for the indication under accelerated approval driven on tumor response rate and duration of response. According to the US pharma giant, continued approval of Lorbrena for the ALK-positive NSCLC indication may be contingent based on verification and description of clinical benefit in a confirmatory trial.
Lorbrena is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). It represents the third FDA approval bagged by Pfizer for an oncology treatment, which includes two lung cancer drugs, inside two months.
Commenting on Lorbrena FDA approval, Andy Schmeltz – Global President of Pfizer Oncology, said:
“Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumor complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors.
“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.”
Pfizer claims that the Lorbrena FDA approval gives a new option for patients who have progressed on a second-generation ALK TKI, while offering an opportunity to continue on oral therapy.
Alice T. Shaw – Professor of Medicine at Harvard Medical School, and Director of the Center for Thoracic Cancers at Massachusetts General Hospital, commenting on Lorbrena FDA approval, said:
“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.
“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.”
Lorbrena FDA approval was driven by the results of a phase 1/2 clinical trial called B7461001, which assessed the Pfizer lung cancer drug on 215 ALK-positive metastatic NSCLC patients who had prior treatment with one or more ALK TKIs.
The non-randomized, dose-ranging and activity-estimating, multi-cohort, multicenter clinical trial demonstrated an overall response rate (ORR) of 48%, and 57% in patients who had prior treatment with more than one ALK TKI.
In the lung cancer trial, 69% of patients had a history of brain metastases and intracranial response rate was 60%.
In addition to the Lorbrena FDA approval, Pfizer also has an approval for the lung cancer drug in Japan for the treatment of ALK fusion gene-positive non-small cell lung cancer with resistance or intolerance to ALK tyrosine kinase inhibitor(s). The Japanese approval is for non-small cell lung cancer in the unresectable advanced and/or recurrent forms.