Bristol Myers Squibb's Lung Cancer Drug Secures FDA Breakthrough Status

Bristol Myers Squibb's (BMY) new drug, iza-bren, receives FDA breakthrough therapy designation for advanced EGFR-mutant lung cancer. Analysts predict an average price target of $51.51, indicating a 6.34% upside from the current market price. GuruFocus estimates a GF Value increase of 10.57%, enhancing BMY's investment appeal.

Bristol Myers Squibb (BMY) has received a significant boost in its efforts to combat advanced EGFR-mutant non-small cell lung cancer (NSCLC) with the FDA granting Breakthrough Therapy Designation (BTD) to its drug, Iza-bren. The designation, announced on August 18, 2025, highlights the potential of this bispecific antibody-drug conjugate (ADC) to address a critical unmet need in patient care.

Iza-bren, developed by SystImmune and Bristol Myers Squibb, is a first-in-class ADC that targets both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3) with a topoisomerase 1 inhibitor payload. The drug has shown promising efficacy and manageable safety profiles in patients with EGFR-mutant NSCLC who have progressed after third-generation EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy.

The FDA's decision was based on data from three ongoing clinical 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. These trials demonstrated evidence of improved efficacy with a manageable safety profile in the targeted patient population.

The Breakthrough Therapy Designation is intended to expedite the development and review of drugs that may demonstrate significant benefit over current standards of care. Analysts predict an average price target of $51.51 for Iza-bren, indicating a 6.34% upside from the current market price. GuruFocus estimates a GF Value increase of 10.57%, enhancing BMY's investment appeal.

Dr. Jonathan Cheng, Chief Medical Officer of SystImmune, stated, "The FDA’s granting of Breakthrough Therapy Designation underscores the potential of iza-bren to meaningfully improve clinical outcomes for patients with previously treated epidermal growth factor receptor mutation NSCLC. The data we have generated to date suggest that iza-bren could address a critical unmet need in patient care, and we look forward to working closely with the FDA to conduct the relevant clinical studies and seek regulatory approval."

Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancer cases, which remains the leading cause of cancer-related death worldwide. Among patients with NSCLC, 10% to 15% in Western populations and up to 50% in Asian populations harbor activating EGFR mutations. These tumors initially respond to EGFR TKIs such as osimertinib but develop resistance after about 18 months, highlighting the need for new, effective therapies.

Iza-bren's dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. Upon antibody-mediated internalization, the drug's therapeutic payload is released, causing genotoxic stress that leads to cancer cell death.

SystImmune is a clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ, specializing in developing innovative cancer treatments using its established drug development platforms. Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases.

References:
[1] https://news.bms.com/news/corporate-financial/2025/Izalontamab-Brengitecan-EGFRxHER3-ADC-Granted-Breakthrough-Therapy-Designation-by-U-S--FDA-for-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer/default.aspx