The US FDA Accepts Merck and Daiichi Sankyo’s BLA for HER3-DXd and Grants Priority Review for the Treatment of Non Small Cell Lung Cancer
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- The BLA was submitted based on the results from the P-II (HERTHENA-Lung01) clinical trial evaluating the safety & efficacy of HER3-DXd in patients with EGFR-mutated locally advanced or metastatic NSCL randomized in the ratio 1:1 to receive 5.6mg/kg of HER3-DXd (n=225) or an uptitration regimen (n=50) which was later discontinued. The PDUFA date assigned is June 26, 2024
- 1EP of the study incl. ORR whereas the 2EPs include DoR, PFS, disease control rate & time to response. Moreover, the study depicted an ORR of 29.8%, 1 CR, 66 partial responses, an mDoR of 6.4mos.
- HER3-DXd (patritumab deruxtecan) is an HER3-directed ADC developed through Daiichi’s proprietary DXd ADC technology. HER3 -DXd received the US FDA’s BTD in Dec 2021
Ref: Merck | Image: Merck
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
