An announcement was made by Bristol-Myers Squibb (BMS) that the European Commission (EC) has expanded the indication of Yervoy to cover the treatment of advanced melanoma in patients 12 years of age and older.
This marks BMS’s first paediatric indication for an immuno-oncology medicine in the EU.
Unmet clinical needs
The outcome will advance treatments for patients with unmet clinical needs and provide an alternative to young patients whose treatment options have been limited.
The drug has been evaluated in young patients across two clinical trials to determine correct dosage, and its use has been supported by evidence from studies of Yervoy in adult patients.
Yervoy is a recombinant human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
By doing so it blocks the interaction of CTLA-4, which results in the augmentation of T-cell activation and proliferation, including the activation and proliferation of tumour-infiltrating T-effector cells.
In 2011, the FDA approved Yervoy 3mg per kg monotherapy for patients with unresectable or metastatic melanoma.
The drug is approved for advanced melanoma in more than 50 countries and there is an ongoing development plan in place for use of Yervoy in other tumour types.
Although Yervoy could make a difference in the lives of young patients, it does not come without risks.
It can result in severe and fatal immune-mediated adverse reactions such as enterocolitis, hepatitis, dermatitis, neuropathy, and endocrinopathy.
Therefore, patients need to be assessed for signs and symptoms of adverse reactions and have their clinical chemistries evaluated during and after administration of each dose.
Although paediatric melanoma is a rare condition, more effective therapeutic approaches are needed for this patient population. Yervoy offers hope for patients with hard-to-treat cancers and could potentially improve outcomes.