Report Details Benefits, Risks of Nivolumab for Squamous NSCLC

This article originally appeared here.
Share this content:
Report Details Benefits, Risks of Nivolumab for Squamous NSCLC
Report Details Benefits, Risks of Nivolumab for Squamous NSCLC

TUESDAY, Oct. 20, 2015 (HealthDay News) -- For patients with metastatic squamous non-small-cell lung cancer (SQ NSCLC), nivolumab has been granted U.S. Food and Drug Administration approval. The benefit-risk summary was reviewed in a report published online Oct. 15 in JAMA Oncology.

Dickran Kazandjian, M.D., from the FDA in Silver Spring, Maryland, and colleagues provided a benefit-risk summary based on a planned interim analysis of a trial in second-line metastatic SQ NSCLC involving 272 patients. Participants were randomized to receive nivolumab (135 patients) or docetaxel (137 patients).

The researchers found that median overall survival was 9.2 and six months for patients randomized to nivolumab and docetaxel, respectively (hazard ratio, 0.59). In a single-arm trial involving 117 patients with previously treated metastatic SQ NSCLC, they assessed the safety of nivolumab; the safety profile was found to be consistent with that in melanoma. There were serious immune-mediated adverse events, which were rare and managed with corticosteroids and dose interruption.

"The FDA granted nivolumab traditional approval on March 4, 2015, for treatment of metastatic SQ NSCLC with progression during or after platinum-based chemotherapy," the authors write. "The approval provides an important treatment option for these patients, affecting routine care and clinical trials."

Abstract
Full Text
Editorial

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease


More in Home

CDC: Too Many Health Care Workers Not Getting Flu Vaccine

CDC: Too Many Health Care Workers Not Getting ...

Vaccination protects both workers and patients

Early Mobilization Improves Outcomes, LOS in Surgical ICUs

Early Mobilization Improves Outcomes, LOS in Surgical ICUs

Patients discharged sooner, become more functional when they leave the hospital

is free, fast, and customized just for you!

Already a member?

Sign In Now »