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# Complete Response on BLA for Lung Cancer Combo
- URL: https://www.fdaweb.com/complete-response-on-bla-for-lung-cancer-combo/
- Published: 2024-06-27T12:00:00.000Z
- Updated: 2026-09-14T14:34:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157268

FDA has issued Daiichi Sankyo and Merck a complete response letter on their BLA for patritumab deruxtecan (HER3-DXd) for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The letter cited findings from an inspection of an undisclosed third-party manufacturing facility, the companies say, adding that it did not identify any issues with the efficacy or safety data submitted.

Patritumab deruxtecan is described as a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by the companies.

“We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3 directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer,” the companies say in a release.

The BLA is based on data from the [HERTHENA-Lung01](https://clinicaltrials.gov/ct2/show/NCT04619004?ref=fdaweb.com) Phase 2 trial that were recently published in the[*Journal* *of Clinical Oncology*](https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fascopubs.org%2Fdoi%2F10.1200%2FJCO.23.01476&data=05%7C01%7Crlipson%40dsi.com%7Cfe94c68c81404e01a2e808dbaf02fada%7Cb0179487302644f7bcd625ed452138d0%7C0%7C0%7C638296199571590565%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=cBgywXDhf%2FVATcS8Of02LtiyH7S8JAnoJR7JeJ74fAk%3D&reserved=0&ref=fdaweb.com). The data demonstrated an objective response rate of 29.8%, including one complete response and 66 partial responses, the companies say. The median duration of response was 6.4 months.