Pfizer Inc., a leading US pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA) for Lorbrena (lorlatinib), a groundbreaking treatment for anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC). This approval marks a significant milestone in the fight against a challenging form of cancer, particularly for patients whose condition has progressed after initial treatment with alectinib or ceritinib.

FDA Approval Details and Conditions

The FDA has granted Lorbrena accelerated approval based on its promising tumor response rate and duration of response in clinical trials. This expedited approval is intended to provide an effective treatment option for ALK-positive NSCLC patients who have not seen sufficient results from earlier therapies. Continued approval of Lorbrena will depend on the results of ongoing confirmatory trials designed to validate its clinical benefits.

Lorbrena is a third-generation ALK tyrosine kinase inhibitor (TKI), designed to target and inhibit specific tumor mutations that may cause resistance to other ALK inhibitors. This approval is Pfizer’s third FDA endorsement for an oncology treatment in just two months, following recent approvals of other lung cancer drugs.

Impact and Expert Commentary

Andy Schmeltz, Global President of Pfizer Oncology, emphasized the significance of Lorbrena’s approval: “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.”

Dr. Alice T. Shaw, Professor of Medicine at Harvard Medical School and Director of the Center for Thoracic Cancers at Massachusetts General Hospital, highlighted the drug’s potential impact: “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.”

Clinical Trial Results

The FDA’s approval was based on the results from a phase 1/2 clinical trial, B7461001, involving 215 ALK-positive metastatic NSCLC patients who had previously been treated with one or more ALK TKIs. This trial, which was non-randomized and multi-cohort, showed an overall response rate (ORR) of 48%, with a higher ORR of 57% in patients who had undergone treatment with multiple ALK TKIs. Notably, 69% of participants had a history of brain metastases, and the intracranial response rate was 60%.

Global Approval and Future Prospects

In addition to its FDA approval, Lorbrena has also received approval in Japan for the treatment of ALK fusion gene-positive NSCLC with resistance or intolerance to previous ALK TKI therapies. The Japanese approval covers advanced and/or recurrent forms of NSCLC that are unresectable.

Pfizer’s continued advancements in oncology underscore its commitment to addressing complex cancer cases and improving patient outcomes with innovative therapies.

  Alice T. Shaw, ALK-positive NSCLC, Andy Schmeltz, Cancer Drug Approval, FDA approval, Harvard Medical School, Lorbrena, Lorlatinib, Lung Cancer Treatment, Massachusetts General Hospital, Oncology, Oncology News, Pfizer, Small cell lung cancer, US FDA, USA