Shots:
- The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin
- Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at ESMO’23, SGO’24, & ESMO’25
- The P-II portion of REJOICE-Ovarian01 will assess R-DXd (4.8, 5.6, or 6.4mg/kg) with 1EP of ORR, while the P-III portion will evaluate 5.6mg/kg against investigator’s choice of CT (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan) with dual 1EPs of ORR & PFS; data to be presented in a future meeting
Ref: Merck| Image: Daiichi Sankyo and Merck | Press Release
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