FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo, Merck's Raludotatug Deruxtecan for Ovarian Cancer Treatment.

Daiichi Sankyo and Merck have received Breakthrough Therapy Designation from the FDA for their raludotatug deruxtecan treatment for adults with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers who have previously been treated with bevacizumab. The designation was granted based on data from a phase 1 study and the ongoing REJOICE-Ovarian01 phase 2/3 study.

Daiichi Sankyo and Merck have received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for their investigational treatment, raludotatug deruxtecan, for adults with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers who have previously been treated with bevacizumab. The designation, which aims to expedite the development and regulatory review of new medicines addressing serious conditions and unmet medical needs, was granted based on data from a phase 1 study and the ongoing REJOICE-Ovarian01 phase 2/3 trial Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab^[1].

Raludotatug deruxtecan is a potential first-in-class antibody drug conjugate (ADC) targeting CDH6, a protein overexpressed in several cancers, including ovarian tumors. The treatment, developed using Daiichi Sankyo’s proprietary DXd ADC Technology, is designed to improve patient outcomes by addressing a significant unmet medical need in this patient population. The FDA’s BTD is a reflection of the promising preliminary clinical results that demonstrate substantial improvement over currently available medicines Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab^[1].

The phase 1 trial, conducted across Asia and North America, evaluated the safety and efficacy of raludotatug deruxtecan in patients with advanced ovarian cancer previously treated with platinum-based chemotherapy and a taxane. The trial enrolled 179 patients and assessed various endpoints, including objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab^[1].

The REJOICE-Ovarian01 phase 2/3 trial, which is expected to enroll approximately 710 patients globally, is assessing the efficacy and safety of raludotatug deruxtecan in patients with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. The primary endpoint of the phase 2 part of the trial is ORR, with secondary endpoints including DoR, PFS, and overall survival (OS) Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab^[1].

Daiichi Sankyo and Merck’s collaboration, which began in October 2023, aims to jointly develop and commercialize several ADC therapies, including raludotatug deruxtecan. The companies are working closely with the FDA to share data from the REJOICE-Ovarian01 trial and continue advancing the development of this potential new treatment option Raludotatug Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with CDH6 Expressing Platinum-Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancers Previously Treated with Bevacizumab^[1].