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Investing.com -- Bristol Myers (NYSE:BMY) Squibb and SystImmune have received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for their experimental drug iza-bren, aimed at treating advanced EGFR-mutant lung cancer.
The designation specifically targets patients with EGFR exon 19 or 21 mutations whose disease has progressed after treatment with EGFR tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy.
Iza-bren functions as a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3 receptors. The drug is being jointly developed by the two companies outside of China under an exclusive licensing agreement.
The FDA’s decision was supported by data collected from three ongoing clinical trials - a global study managed by SystImmune and two trials in China conducted by Biokin.
Early evidence from these studies has demonstrated improved efficacy with a manageable safety profile.
This regulatory milestone could potentially accelerate the development and review process for iza-bren in treating this specific subset of lung cancer patients who have limited treatment options after standard therapies fail.
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