Melanoma Treatment Yervoy Approved by FDA but Includes SJS warning

The melanoma treatment drug Yervoy has been approved by the FDA recently, but the warning label includes information about the risks of patients developing Stevens-Johnson syndrome (SJS).

According to information posted on Investorideas.com, Yervoy is the “first and only approved therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival.” This information is based on results from a random, double blind study Phase 3 study.

Bristol-Myers Squibb announced the approval by the FDA of Yervoy (ipilimumab) in 3 mg/kg dosages. The drug will be used to treat patients who are suffering from an inoperable form of melanoma, which is a type of skin cancer.

While this may sound like good news to sufferers of metastatic melanoma, the drug does have side effects. The warning label includes the information that Yervoy could cause patients to suffer from severe and fatal immune-mediated reactions because of T-cell activation and proliferation. The most common raction with using Yervoy have been listed as enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy and endocrinopathy.

Another warning associated with the newly-approved Yervoy is called immune-mediated dermatitis. The specific warning listed states: “In the pivotal Phase 3 study in YERVOY-treated patients, severe, life-threatening or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3–5) occurred in 13 (2.5%) of patients.”

The warning also showed that 1 (0.2%) patient died of toxic epidermal necrolysis while taking Yervoy. Stevens-Johnson syndrome and toxic epidermal necrolysis have been getting more well-known as more and more patients are suffering from the devastating condition, but warning labels often bury mention of SJS and TENS in a pile of technical information that can be hard to understand.

If you or a family member develops SJS or TENS, contact a doctor immediately, and then call SJS lawyer Greg Jones for a free consultation. I am experienced at fighting SJS and TENS lawsuits and I will work hard to help you get every dime that you may be entitled to.

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