Daiichi Sankyo Submits sNDA for Ezharmia to the Japan MHLW for the Treatment of Peripheral T-Cell Lymphoma (PTCL)
Shots:
- The sNDA was filled based on the results from the P-II (VALENTINE-PTCL01) trial evaluating the safety & efficacy of Ezharmia in patients with r/r PTCL (Cohort 1) & ATLL (Cohort 2). The 1EP is ORR & 2EPs are DoR, CR, PR, duration of CR, PFS
- The results depicted an ORR of 43.7% in PTCL patients (n=119), 17 CRs, 35 PRs, mDoR of 11.9mos. (at median follow-up of 9.7mos.), mPFS of 5.5mos. (at median follow-up of 11.3mos.) & mOD of 17mos. (at median follow-up of 12.3mos.). The results were presented at the ASH meeting 2023
- Ezharmia is a dual inhibitor of EZH1 & EZH2 approved in Japan to treat patients with r/r ATLL. Additionally, Ezharmia has received the SAKIGAKE Designation by the Japan MHLW for r/r PTLCL
Ref: Daiichi Sankyo | Image: Daiichi Sankyo
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
