The U.S. Food and Drug Administration (FDA) has started the clock on its review of ivonescimab, a bispecific anticancer drug submitted by U.S.-based Summit Therapeutics.
The regulator initiated the review to assess ivonescimab’s efficacy in combination with chemotherapy for patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have previously been treated with targeted inhibitors. The target decision date is set for November 14, Pharma Phorum reports.
Bispecific VEGFxPD-(L)1 drugs have become one of the most discussed recent topics in oncology after ivonescimab — initially developed by China’s Akeso — demonstrated superior survival outcomes over MSD’s blockbuster Keytruda (pembrolizumab) in PD-L1-positive NSCLC.
The FDA’s decision is based on results from a Phase III study comparing ivonescimab plus chemotherapy to chemotherapy alone in patients previously treated with a third-generation EGFR inhibitor, such as AstraZeneca’s Tagrisso (osimertinib).
Summit secured the rights to ivonescimab for $5 billion, including a hefty $500 million upfront payment, in 2022. The drug is already approved in China under the brand name Yi-Ke for the treatment of EGFR-positive non-small cell lung cancer that has progressed after prior EGFR inhibitor therapy.
