Sesen Bio Announces Successful Type C Meeting with FDA for Vicinium
Sesen Bio, Inc. (SESN)
Last sesen bio, inc. earnings: 11/12 07:00 am
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Source: Business Wire
Alignment reached with FDA on post-marketing confirmatory trial design CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today reported alignment with the FDA on the design of its post-marketing confirmatory trial for Vicinium.Sesen Bio reached agreement with the FDA that the post-marketing confirmatory trial for Vicinium will enroll BCG-refractory patients who have received less-than-adequate BCG*, which is especially important in light of the ongoing BCG shortage. This represents a broader patient population than the originally proposed BCG-intolerant population. It is anticipated that, if Vicinium is approved by the FDA, the initial indication will be for BCG-unresponsive patients who have received adequate BCG. However, assuming the post-marketing confirmatory trial is successful, it is expected that labeling will be expanded to include this additi
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