Mersana Therapeutics Receives FDA Fast Track Designation for XMT-1536 for the Treatment of Patients with Platinum-resistant Ovarian Cancer
“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,” said
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill unmet medical needs. A drug granted Fast Track Designation may be eligible for several benefits, including more frequent meetings and communications with the FDA and, if certain criteria are met, the potential for Accelerated Approval, Priority Review or Rolling Review of a Biologics License Application (BLA).
XMT-1536, a first-in-class ADC targeting the sodium-dependent phosphate transport protein NaPi2b, utilizes the Dolaflexin platform to deliver an average of 10-12 DolaLock payload molecules per antibody. The NaPi2b antigen is broadly expressed in ovarian cancer and non-small cell lung cancer (NSCLC) adenocarcinoma. 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. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov (NCT03319628).
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Source: Mersana Therapeutics, Inc.