SystImmune: FDA Grants Breakthrough Therapy Designation For Iza-bren

(RTTNews) - SystImmune and Bristol Myers Squibb (BMY) announced the FDA has granted Breakthrough Therapy Designation to izalontamab brengitecan or iza-bren for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy.

The decision was based on data from three ongoing trials: BL-B01D1-101 and BL-B01D1-203, conducted in China by Sichuan Biokin Pharmaceutical Co., Ltd., and the global BL-B01D1-LUNG-101 study conducted by SystImmune across the United States, Europe and Japan.

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