India, Oct. 1 -- Cullinan Therapeutics (CGEM) announced that it has initiated submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration for zipalertinib in combination with platinum-based chemotherapy as a first-line treatment for patients with EGFR exon 20 insertion - mutated non-small cell lung cancer (NSCLC).
The submission is being made under the FDA's Real - Time Oncology Review (RTOR) program.
Non-small cell lung cancer is the most common form of lung cancer. A small percentage of patients carry EGFR exon 20 insertion mutations, which are associated with limited treatment options and historically poorer outcomes than more common EGFR mutations.
The FDA's RTOR program allows sponsors to submit clinical data...