Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for the treatment of advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations. This designation is based on efficacy and safety data from three clinical trials, including two conducted in China and one global study across the United States, Europe, and Japan. The trials indicated potential improved efficacy and a manageable safety profile for patients with EGFR-mutant NSCLC who progressed after receiving third-generation EGFR tyrosine kinase inhibitors and platinum-based chemotherapy. No specific dates for future presentations of these results have been mentioned in the announcement.
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