FDA has granted fast track designation for XMT-1536 for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have:
Received up to three prior lines of systemic therapy or
Have received four prior lines of systemic therapy regardless of platinum status
XMT-1536 is in an ongoing Phase 1 proof-of-concept clinical trial in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma
Mersana bags FDA Fast Track Designation for XMT-1536
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Our outlook:
This FTD will be an important milestone in the development of XMT-1536. XMT-1536 appears to be well tolerated, with promising responses shown in high grade serous ovarian cancer
With unmet need in platinum-resistant ovarian cancer and designation in hand, the product upon showing promising results can rapidly advance in development
– Dr. Kowndinya, CI Scientists
Background:
XMT-1536 is lead product candidate, composed of XMT-1535, a proprietary, humanized monoclonal antibody against human sodium-dependent phosphate transport protein 2B (NaPi2b), site-specifically linked, via a protease cleavable linker, to the proprietary cytotoxic aurastatin derivative auristatin F-HPA (auristatin F-hydroxypropylamide), with potential antineoplastic activity
XMT-1536 is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma