Pfizer's LORBRENA approval expanded to treat ALK-positive Metastatic Cancer

Pfizer's LORBRENA approval expanded to treat ALK-positive Metastatic Cancer

The drug is specifically designed for common tumor mutations and to address metastases in the brain

Pfizer Inc.'s supplemental New Drug Application for LORBRENA has been approved by the US Food and Drug Administration (FDA). The approval expands the indication to include the first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Andy Schmeltz, Global President, Pfizer Oncology said, "For more than a decade, Pfizer has been a pioneer in delivering biomarker-driven therapies and addressing the diverse and evolving needs of people with non-small cell lung cancer. LORBRENA has been a transformative medicine for people with ALK-positive advanced NSCLC, and this FDA approval in the first-line setting means that we can now extend hope to even more people."

The drug is specifically designed for common tumor mutations and to address metastases in the brain. The metastases in the brain form a site for disease progression in the ALK-positive NSCLC where maximum people are initially diagnosed with such metastases. FDA converting the 2018 accelerated approval to full approval is a major move for Pfizer, getting approval under the FDA's Real-Time Oncology Review (RTOR) pilot program.

The result of the Phase 3 CROWN trial showed a 72 per cent reduction in risk of progression or death as compared to another drug XALKORI. The drug was applied to a previously untreated patent population involving the assessment of the Central Nervous System. While assessing, there were 17 patients in the LORBRENA arm and 13 in the XALKORI arm having measurable brain metastases based on baseline brain imaging. LORBRENA scored 82 per cent in the intracranial objective response rate while XALKORI scored 23 pee cent among patients.

Benjamin Solomon, M.D., Department of Medical Oncology, Peter MacCallum Cancer Centre said, "The CROWN data have shown LORBRENA can significantly improve outcomes in the first-line treatment of ALK-positive non-small cell lung cancer, including those that present with brain metastases. This approval is meaningful for my patients because we now have a highly effective treatment option that can delay the progression of typically aggressive disease."

Talking about the crown trial, it is a Phase 3, randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive LORBRENA. The NSCLC has been the cause of cancer-related death around the world accounting for 80-85 per cent of lung cancer with ALK-positive tumor estimating to 2 lakh cases diagnosed in the US. LORBRENA was specifically developed to inhibit the tumor mutations that drive assistance to other ALK inhibitors penetrating blood-brain cancer. LORBRENA being a tyrosine kinase inhibitor is highly active.