August 11, 2020
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FDA grants fast track designation to XMT-1536 for ovarian cancer subset

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The FDA granted fast track designation to XMT-1536 for the treatment of women with high-grade serous ovarian cancer, according to a press release from the agent’s manufacturer.

This designation for XMT-1536 (Mersana Therapeutics), an antibody-drug conjugate, applies to women with platinum-resistant disease who have received up to three prior lines of systemic therapy or women who have received four prior lines of systemic therapy regardless of platinum status.

Sign outside FDA HQ in Washington, DC.

XMT-1536 targets the sodium-dependent phosphate transport protein NaPi2b, an antigen expressed in ovarian cancer and non-small cell lung cancer adenocarcinoma. The agent is being evaluated in a phase 1 proof-of-concept clinical trial of patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma.

“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 the release. “With this designation in hand, we plan to be able to quickly advance through the administrative steps of XMT-1536’s development and bring forth a therapy for these patients as soon as possible.”