A little more than a year after Roche won an accelerated approval for Alecensa as a new drug for treatment-resistant ALK-positive non-small cell lung cancer, the cancer drug powerhouse has trumped Pfizer’s Xalkori as a frontline therapy, beating out their rival on progression-free survival.
Roche won the first approval for Alecensa based on evidence of tumor shrinkage in Phase II. Researchers also highlighted a 61% response rate in patients with brain or CNS metastases to help distinguish the new arrival.
Genentech is holding back the data from Phase III for now, until they can review it at an upcoming conference.
The team at Genentech working on their big ALEX study picked up the FDA’s breakthrough therapy designation for frontline use of their drug last fall, giving Roche a likely quick turnaround on the agency’s stamp of approval as they expand their market for this drug.
“Our goal is to transform the standard of care and we are excited to share these results with the lung cancer community,” said Sandra Horning, Chief Medical Officer and Head of Global Product Development. “As part of its Breakthrough Therapy Designation, we hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible and will discuss these data with global health authorities.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 29,000+ biopharma pros who read Endpoints News by email every day.Free Subscription