Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S). This designation is for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have experienced disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy.
The BTD aims to expedite the development and review of investigational medicines for serious or life-threatening diseases where preliminary clinical evidence suggests substantial improvements over available therapies. This designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the Phase 1/2 RAINFOL-01 trial.
Rina-S is advancing through late-stage development, supported by a growing portfolio of clinical trials, including the ongoing Phase 3 RAINFOL-02 trial in ovarian cancer and planned Phase 3 trials in endometrial cancer. This designation underscores the potential of Rina-S to redefine treatment possibilities for women with advanced endometrial cancer.
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