Elahere receives orphan drug designation in Korea
By Eo, Yun-Ho | translator Alice Kang
25.01.16 05:06:00
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Confirmed improvement in overall survival through the Phase III MIRASOL study
Gains attention as a first-in-class drug in an area lacking treatment options
The Ministry of Food and Drug Safety (MFDS) recently announced the designation through the first orphan drug designation announcement of the new year.
Specifically, the drug is indicated as monotherapy in adult patients with folate receptor-alpha (FR¥á) positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received one to three prior systemic therapies and have not responded to or are no longer responding to treatment with platinum-based chemotherapy.
AbbVie¡¯s Elahere(mirvetuximab soravtansine) first received accelerated approval in the U.S. in November 20
Eo, Yun-Ho(unkindfish@dailypharm.com)
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