The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren), an investigational drug developed by SystImmune and Bristol Myers Squibb, for certain patients with advanced non-small cell lung cancer (NSCLC).
The designation applies to patients whose tumours have specific epidermal growth factor receptor (EGFR) gene mutations, and whose cancer has progressed despite earlier treatment with targeted EGFR medicines and chemotherapy.
Iza-bren is an antibody-drug conjugate, designed to block both the EGFR and HER3 proteins – which are attributed to cancer cell growth – while delivering a toxic agent to destroy them.
The FDA’s decision is based on results from three ongoing studies in China, the US, Europe and Japan. Results indicate that iza-bren may offer better tumour control than existing options, with side effects that are deemed manageable.
“The FDA’s granting of Breakthrough Therapy Designation underscores the potential of iza-bren to meaningfully improve clinical outcomes for patients with previously treated EGFR mutation NSCLC,” said Jonathan Cheng, chief medical officer at SystImmune.
Lung cancer remains the leading cause of cancer-related death worldwide. Treatment options after resistance to standard therapies are currently limited, reiterating the need for therapeutic candidates such as iza-bren.
