FDA Expands Ipilimumab Indication to Include Pediatric Unresectable or Metastatic Melanoma

Share this content:
The FDA approved the indication expansion for ipilimumab based on evidence from 2 clinical trials evaluating its safety and efficacy in pediatric patients.
The FDA approved the indication expansion for ipilimumab based on evidence from 2 clinical trials evaluating its safety and efficacy in pediatric patients.

The US Food and Drug Administration (FDA) announced today that it has expanded the indication of intravenous (IV) ipilimumab to include the treatment of pediatric patients with unresectable or metastatic melanoma who are 12 years of age and older.1

Ipilimumab is a CTLA-4 inhibitor previously indicated for patients aged 12 years and older who have undergone complete resection for cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm.

The FDA approved the indication expansion based on evidence from 2 clinical trials that evaluated the drug's safety and efficacy in pediatric patients.

In a dose-determining trial, IV ipilimumab was administered to 33 pediatric patients with relapsed or refractory solid tumors at doses of 1, 3, 5, and 10 mg/kg over 90 minute infusions every 3 weeks for 4 cycles, then was continued every 12 weeks until progression or discontinuation.

In another trial, IV ipilimumab 3 mg/kg or 10 mg/kg was administered over 90 minutes to 12 pediatric patients with previously treated or untreated unresectable stage III or IV malignant melanoma for 3 weeks for 4 cycles.

The trials resulted in 17 patients experiencing objective responses, as well as 1 partial response that was sustained for 16 months. The approved dose is 3 mg/kg IV administered over 90 minutes every 3 weeks for 4 cycles. 

The most frequently observed adverse events associated with ipilimumab are immune-mediated and include enterocolitis, dermatitis, hepatitis, endocrinopathy, and neuropathy.

Reference

1. U.S. Food and Drug Adminsitration expands approval of Yervoy® (ipilimumab) to include pediatric patients 12 years and older with unresectable or metastatic melanoma [news release]. Princeton, NJ: Bristol-Myers Squibb; July 24, 2017. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-expands-approval-yervoy-ipilim. Accessed July 24, 2017.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs