FDA lifts hold on Mersana cancer trial

Sep 17, 2018

Mersana Therapeutics announced that the U.S. FDA has lifted a partial clinical hold on its phase I trial of its cancer treatment, XMT-1522.

A partial hold was imposed in July after a patient enrolled in the trial died. Under the hold, no new patients were enrolled in the trial — which is testing the drug in individuals with breast, gastric and non-small cell lung cancers -- but the trial continued on for patients who were already participating.

The Massachusetts-based clinical-stage biopharmaceutical company said they reached alignment with the FDA on changes to the protocol, including increased monitoring as well as the exclusion of patients with advanced hepatic impairment.

“We are excited to resume enrollment on the XMT-1522 trial and to work with investigators to explore the full potential of both promising drug candidates in the solid tumor setting,” said Anna Protopapas, Chief Executive Officer of Mersana.

Read the press release

Want to get news like this in your inbox?  Subscribe to our eNewsletter here!

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments