XMT-1536 on FDA Fast Track for Platinum-resistant, Advanced Ovarian Cancer

XMT-1536 on FDA Fast Track for Platinum-resistant, Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has given  fast track designation to Mersana TherapeuticsXMT-1536 as a possible treatment for women with platinum-resistant high-grade serous ovarian cancer who received up to three prior lines of therapy. The designation also covers those who were treated with four different systemic therapies, regardless of their platinum-disease status. Fast track is meant to facilitate the development and accelerate the review of new medications that aim to treat serious conditions and fill an unmet medical need. Medications given this designation are also eligible for a series of benefits, including the potential for accelerated approval and priority review. “We are very encouraged by the FDA’s decision to grant us Fast Track Designation for our lead program XMT-1536, which has shown very encouraging activity and tolerability in our Phase 1 study in ovarian cancer to date. We believe this recognition underscores the high unmet medical need for a treatment for patients with platinum-resistant ovarian cancer,” Anna Protopapas, president and CEO of Mersana Therapeutics, said in a
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