The China’s Center for Drug Evaluation (CDE) website has indicated that Huadong Medicine Co., Ltd (SHE: 000963) is moving forward with a priority review for its mirvetuximab soravtansine, an antibody drug conjugate (ADC), for potential use in folate receptor α (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has been previously treated with one to three systemic therapies.
Background on Mirvetuximab Soravtansine and Its Development Rights
Mirvetuximab soravtansine, which targets FRα, was originally developed by US-based ImmunoGen Inc. In October 2020, Huadong Medicine acquired the development and commercialization rights for the ADC in a significant USD 305 million licensing deal. This strategic acquisition positioned Huadong to expand its presence in the oncology therapeutics market.
Positive Results from the SORAYA Study
The pivotal single-arm SORAYA study for mirvetuximab soravtansine has achieved its primary endpoint, with a confirmed objective response rate (ORR) of 32.4% for ovarian cancer patients. This milestone supports the potential efficacy of the drug in treating FRα positive cancers and strengthens the case for its priority review.
Ongoing Assessments and Combination Therapies
Mirvetuximab soravtansine is also under assessment in combination with other therapies for ovarian cancer, including bevacizumab and carboplatin. These combination studies aim to further explore the drug’s potential to improve treatment outcomes in patients with platinum-resistant diseases.-Fineline Info & Tech
