Genmab A/S said Tuesday the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its experimental cancer drug, rinatabart sesutecan, for a type of advanced endometrial cancer.
The designation, which aims to expedite the development and review of drugs for serious conditions, applies to adult patients whose recurrent or progressive cancer has worsened after treatment with platinum-based chemotherapy and another common therapy.
According to the company, the FDA's decision was supported by data from a Phase 1/2 trial that showed encouraging responses in heavily pretreated patients.
Results from that trial, presented in June, showed a confirmed objective response rate of 50% in one patient group.
“This Breakthrough Therapy Designation underscores the future potential of Rina-S as a treatment option for women diagnosed with advanced endometrial cancer, who face a poor prognosis after progressing on standard of care treatment,” said Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab.
Rinatabart sesutecan, an antibody-drug conjugate designed to deliver a cancer-killing agent directly to tumor cells, is also being evaluated in a late-stage trial for ovarian cancer.
Genmab said it plans to further evaluate the drug in a Phase 3 trial for endometrial cancer.
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Genmab A/S said Saturday that updated data from a mid-stage trial showed its experimental drug, rinatabart sesutecan, demonstrated sustained anti-tumor activity in patients with advanced endometrial cancer.