What's Happening?
The FDA has commenced its review of Summit Therapeutics' ivonescimab, a bispecific drug targeting VEGF and PD-(L)1, for the treatment of non-small cell lung cancer (NSCLC). This review follows promising
results from the phase 3 HARMONi trial, which showed the drug's efficacy in combination with chemotherapy for patients with EGFR-mutated NSCLC. Ivonescimab, originally developed by Akeso in China, has shown potential in extending survival in PD-L1-positive NSCLC patients. The FDA's decision to review the drug is based on its performance in clinical trials, despite mixed results in international studies.
Why It's Important?
The FDA's review of ivonescimab represents a significant step forward in the development of bispecific drugs for cancer treatment. If approved, this drug could offer a new therapeutic option for patients with NSCLC, particularly those who have not responded to existing treatments. The review also highlights the growing interest in bispecific drugs, which have the potential to target multiple pathways in cancer cells, offering more effective treatment options. The outcome of this review could influence future research and development in oncology, as well as impact the competitive landscape of cancer therapies.
