New Transplant Guidance Recommends Endpoints, Trial Designs for CMV Drugs
Sponsors of drugs to treat or prevent cytomegalovirus (CMV) disease in organ or stem cell transplant patients may use CMV blood levels (CMV viremia) as a validated surrogate endpoint, according to a guidance the FDA finalized last week.
For trials of preventive therapies, participants should have no detectable post-transplant CMV infection within five days of beginning therapy. Treatment trials should enroll organ transplant patients with virological evidence of CMV replication or stem cell transplant recipients with clinical evidence of tissue-invasive CMV disease.
Read the final guidance here: https://bit.ly/2YXh0xd.