FDA grants breakthrough therapy status to SystImmune, BMS lung cancer drug

REDMOND/PRINCETON - The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to izalontamab brengitecan (iza-bren) for treating certain types of advanced non-small cell lung cancer, SystImmune Inc. and Bristol Myers Squibb (NYSE:BMY), a prominent $98.6 billion pharmaceutical company with robust annual revenues of $47.7 billion, announced Monday. According to InvestingPro data, BMY maintains a strong gross profit margin of 73.92%, highlighting its operational efficiency in drug development and commercialization.

The designation applies to iza-bren for locally advanced or metastatic non-small cell lung cancer with specific EGFR mutations in patients whose disease progressed after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. Bristol Myers Squibb, which InvestingPro analysis shows maintains a "GOOD" overall financial health score, continues to demonstrate its commitment to innovative cancer treatments while delivering a substantial 5.12% dividend yield to shareholders.

Iza-bren is a bispecific antibody-drug conjugate targeting both epidermal growth factor receptor and human epidermal growth factor receptor 3 with a topoisomerase 1 inhibitor payload. The drug is being developed by Biokin in China and jointly developed by SystImmune and Bristol Myers Squibb in territories outside China.

The FDA’s decision was based on data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203 conducted in China, and the global BL-B01D1-LUNG-101 study across the United States, Europe and Japan. According to the press release statement, iza-bren demonstrated evidence suggesting improved efficacy with a manageable safety profile in the target patient population.

Non-small cell lung cancer accounts for approximately 80% of all lung cancer cases. Among NSCLC patients, 10% to 15% in Western populations and up to 50% in Asian populations have activating EGFR mutations. While these tumors initially respond to EGFR TKIs, resistance typically develops after about 18 months.

The Breakthrough Therapy Designation is intended to expedite the development and review of drugs that may demonstrate significant benefit over current standards of care.

This marks the first Breakthrough Therapy Designation in the U.S. for the drug, according to the companies’ press release statement. Based on InvestingPro’s Fair Value analysis, Bristol Myers Squibb currently appears undervalued, suggesting potential upside for investors. For detailed insights into BMY’s valuation and 12+ additional ProTips, including extensive financial metrics and expert analysis, explore the comprehensive Pro Research Report available on InvestingPro.

In other recent news, BioNTech SE reported a significant increase in its second-quarter 2025 revenue, doubling year-over-year to €260.8 million. This figure far surpassed analyst expectations of €137.9 million. Despite the revenue growth, BioNTech posted a net loss of €386.6 million, equating to -€1.60 per share, which was slightly below the anticipated -€1.41 per share. Meanwhile, Bristol-Myers Squibb’s stock price target was adjusted by Cantor Fitzgerald, lowering it from $55.00 to $45.00 while maintaining a Neutral rating. The firm highlighted mixed quality in Bristol’s earnings, attributing the top-line beat to legacy products and foreign exchange effects. Cantor Fitzgerald suggested that investors should pay attention to the forthcoming Cobenfy ADEPT-2 top-line results. These developments reflect ongoing changes and expectations in the biotechnology and pharmaceutical sectors.

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