Announced details
First-line treatment of previously untreated locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
Taiho Pharmaceutical submitted a New Drug Application to the FDA. Taiho Pharmaceutical is our wholly owned subsidiary.
The US drug regulatory authority. It conducts reviews under the RTOR program and PDUFA.
There is currently no change to the consolidated earnings forecast for the fiscal year ending December 2026. The company positions zipalertinib as one of the products that will drive future growth and describes this matter as important progress toward enhancing corporate value over the medium to long term.
The company does not address Contract Value / Offering price.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Combination therapy consisting of zipalertinib and platinum-based chemotherapy |
| Counterparty | U.S. Food and Drug Administration (FDA) |
| Counterparty overview | The US drug regulatory authority. It conducts reviews under the RTOR program and PDUFA. |
| Relationship with the Company | Taiho Pharmaceutical submitted a New Drug Application to the FDA. Taiho Pharmaceutical is our wholly owned subsidiary. |
| Applicable area | First-line treatment of previously untreated locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations |
| Impact on Business Performance | There is currently no change to the consolidated earnings forecast for the fiscal year ending December 2026. The company positions zipalertinib as one of the products that will drive future growth and describes this matter as important progress toward enhancing corporate value over the medium to long term. |
Items this document does not state (12)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The application was submitted under the FDA's RTOR program, which allows the review of clinical trial data to begin at an early stage. The company positions zipalertinib as one of the products that will drive future growth and describes this as important progress toward enhancing corporate value over the medium to long term.