Based on the results from a clinical trial, BI 1482694, a product of pharmaceutical company Boehringer Ingelheim, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA).
BI 1482694 is an epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI) that trials have shown to be effective in treating patients living with advanced and pre-treated EGFR mutation-positive non-small cell lung cancer (NSCLC).
"The clinical trial results we have seen so far for BI 1482694 are very encouraging and have led to the FDA Breakthrough Designation and a first regulatory submission in Korea," Dr. Mehdi Shahidi, medical head of solid tumor oncology for Boehringer Ingelheim, said. "The T790M mutation is the most common resistance mechanism found in about half of the patients previously treated with currently available EGFR TKIs. Our aim at Boehringer Ingelheim is to prolong the continuum of treatment with targeted therapies for patients with EGFR mutation-positive lung cancer with a treatment that could potentially be efficacious even after the inevitable occurrence of resistance to the initial treatment."
The trial showed BI 1482694's disease control rate for EGFR mutation-positive lung cancer to be 91 percent.
"These data further validate BI 1482694 as a potential treatment for lung cancer patients who encounter resistance to first or second-generation EGFR targeting treatments," Keunchil Park, coordinating investigator, said. "Being able to improve outcomes of EGFR mutation-positive patients with minimum burden on their overall well-being is the goal for both patients and oncologists, so we eagerly await the duration of response and progression-free survival data from this study, as well as results of the broader clinical program which is underway."
