FDA Approves YERVOY (ipilimumab) for Pediatric Melanoma

In July 2017, YERVOY (manufactured by Bristol-Myers Squibb) received expanded approval from the United States Food & Drug Administration. First approved for adult patients in 2011, the FDA now permits YERVOY for the treatment of unresectable or metastatic melanoma in pediatric patients 12 years and older.

YERVOY (generic name: ipilimumab) is an immuno-oncology medicine that helps the body’s immune system to increase the activity of T-cells. Since it was first approved in 2011, YERVOY has been used to treat melanoma in more than 38,000 adult patients.

YERVOY is given as an intravenous (IV) infusion at a doctor’s office. The approved dose for pediatric patients is 3 mg/kg, administered intravenously over 90 minutes every three weeks for a total of four doses.

“Despite significant advancements in oncology research for adults in recent years, treatment options continue to be limited for pediatric patients with metastatic melanoma... This latest approval of Yervoy exemplifies our ongoing effort to expand the availability of therapies for younger cancer patients.” -Chris Boerner, PhD, president and head of U.S. commercial operations, Bristol-Myers Squibb.

The recent approval for pediatric patients was announced after two clinical trials involving a total of 45 pediatric patients.

Yervoy indications and side effects

YERVOY is indicated for:

  • Unresectable or metastatic melanoma in adult patients
  • Unresectable or metastatic melanoma in pediatric patients (12 years and older)
  • Cutaneous melanoma with pathological involvement of regional lymph nodes (in certain circumstances, as adjuvant treatment)

Some serious side effects can occur with YERVOY, including:

  • Fatigue
  • Diarrhea
  • Pruritus (severe itching)
  • Rash
  • Colitis (inflammation in the colon)

Due to an increased risk of immune-mediated adverse reactions, patients receiving YERVOY should be monitored for enterocolitis, dermatitis, neuropathy, and endocrinopathy. This medication may not be safe for pregnant or nursing women.

Click here for full prescribing and safety information.

For help paying for YERVOY, including co-pay assistance, check out the BMS Access Support Program.

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