FDA Fast Track Designation granted to BNT325/DB-1305
“The FDA’s decision is an important recognition of the potential of our TROP2-targeting ADC candidate. Platinum-based chemotherapy is the backbone of treatment for ovarian epithelial cancer and related subtypes that form in the epithelial tissue. Patients with platinum resistance who relapse within under six months have a poor prognosis, and effective and well-tolerated treatment options remain a substantial unmet medical need,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. “Recent studies have indicated the role of TROP2 in aggressive tumor growth and progression in patients with chemotherapy-resistant ovarian tumors. We are committed to further advancing BNT325/DB-1305 and believe that a TROP2-targeted treatment approach has the potential to overcome current limitations in the treatment of advanced ovarian cancers.”
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