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FDA/Panel Decisions

SystImmune: FDA Grants Breakthrough Therapy Designation For Iza-bren

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

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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Global Economics Weekly Update - Jun 08-12, 2026

June 12, 2026 17:14 ET
Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.