Otsuka Holdings subsidiary Daikochi Kogyo has started the New Drug Application process for its lung cancer drug Zeprelertinib in the United States. The company aims to complete the application by late 2026, leveraging an expedited review program to potentially accelerate market entry.
Otsuka Holdings (Headquarters: Minato-ku, Tokyo; CEO: Makoto Inoue) disclosed on October 2 that its subsidiary Daikochi Kogyo has begun a New Drug Application with the US Food and Drug Administration for Zeprelertinib, a treatment for non-small cell lung cancer. The drug targets EGFR exon 20 insertion mutations in newly diagnosed locally advanced or metastatic NSCLC patients.
The application follows the Real-Time Oncology Review (RTOR) program, which allows clinical trial data to be submitted to the FDA prior to the complete filing. This facilitates early assessment of efficacy and safety data. Otsuka views this as a key milestone for long-term value creation and considers Zeprelertinib a core driver of future growth.
While the NDA submission is scheduled for completion by late 2026, the company states there are no changes to its consolidated earnings forecast for the fiscal year ending December 2026. Advancement toward diversified business structure through early approval
The application is supported by Phase III trial REZILIENT3 results. Interim analysis showed that the group receiving Zeprelertinib combined with chemotherapy achieved statistically significant and clinically meaningful improvements in progression-free survival compared to chemotherapy alone, meeting primary endpoints.
Zeprelertinib is an oral low-molecule compound targeting EGFR activation mutations, developed as a next-generation irreversible EGFR inhibitor for NSCLC with ex20ins mutations. Developed by Daikochi Kogyo and Taiho Oncology, Inc., it is being pursued in the US through collaboration with Cullinan Therapeutics, Inc.
Separately, an NDA for monotherapy use is under FDA review, with a Prescription Drug User Fee Act target date of February 27, 2027. Potential for market expansion through combination therapy
In non-small cell lung cancer, the most common type of lung cancer, EGFR exon 20 insertion mutations are a critical treatment target. Data indicates these mutations appear in approximately 4% of NSCLC cases globally, and about 16% of NSCLC patients in the US have an EGFR mutation.
Detailed breakdowns report that up to 12% of all EGFR mutations are ex20ins variants (Source: Riess JW et al. J Thorac Oncol. 2018). Despite a clearly defined patient population, limited treatment options have existed, creating hope for expanded therapeutic choices with new drugs.
Untapped potential in this target patient group remains significant
Analyst take
This disclosure highlights a strategic move beyond mere submission, as Otsuka is utilizing the Real-Time Oncology Review program. This mechanism allows for earlier data review by the FDA, potentially shortening the approval timeline compared to standard processes. In the highly competitive lung cancer market, speed to market is critical for securing share. Investors should monitor the late 2026 application completion and the February 2027 review target as key milestones. Furthermore, the combination therapy approach may address a broader patient population than monotherapy alone, suggesting potential for greater market impact.
