File photo: Taiho Pharmaceutical headquarters in Tokyo in May 2023. Photo: Asanagi / Wikimedia Commons / CC0 1.0. Cropped.
Taiho Oncology has completed an application asking the U.S. Food and Drug Administration to approve zipalertinib with chemotherapy as an initial treatment for a genetically defined group of patients with advanced lung cancer.
Its development partner, Cullinan Therapeutics, said Nov. 12 that the filing covers previously untreated, locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. These are changes in a gene that can help cancer grow.
Completing an application is not an approval. Cullinan said zipalertinib remains investigational and has not been approved by any health authority.
What the application covers
The proposed treatment would pair the oral medicine with platinum-based chemotherapy. It is intended for patients whose cancer has spread beyond its original site or is locally advanced, and whose tumors carry the specified mutation.
The application is based on the Phase 3 REZILIENT3 study, which compared zipalertinib plus chemotherapy with chemotherapy alone.
At an interim analysis, the combination improved the study’s main measure, median progression-free survival, according to Cullinan. That measure tracks how long patients live without their cancer worsening. It is not the same as overall survival, which measures how long patients live regardless of whether the cancer progresses.
The company called the difference statistically significant but did not include the numerical survival results or detailed side-effect rates in this announcement. It said the study findings had already been presented at the 2026 World Conference on Lung Cancer.
FDA review is the next step
Taiho submitted the application through the FDA’s Real-Time Oncology Review program. That program lets companies send clinical information before the full application is complete so the agency can begin reviewing key data earlier.
Cullinan said the completed application will go through the FDA’s standard review process. If the agency accepts it, a target date for a decision will be assigned. The announcement did not give a decision date for this application.
Zipalertinib is being developed by Taiho Oncology, its parent Taiho Pharmaceutical and Cullinan in the United States. Cullinan is eligible for a $100 million milestone payment if the drug wins U.S. approval for this first-line use. A separate $30 million milestone is tied to approval for second-line treatment, after earlier therapy. Neither payment was announced as earned.
JBizNews Desk | Cambridge, Massachusetts
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