19 December 2017 - - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of New York, New York-based biopharmaceutical company Bristol-Myers Squibb's (NYSE: BMY) Yervoy (ipilimumab) for pediatric patients 12 years of age and older who have unresectable or metastatic melanoma, the company said.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
Yervoy was evaluated in two trials of pediatric patients: a dose-finding study in 33 patients aged two to 21 years with relapsed or refractory solid tumors and an open-label, single-arm trial in 12 adolescents (ages ranging from 12 to 16 years) with previously treated or untreated, unresectable Stage III or IV malignant melanoma.
Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), a negative regulator of T-cell activity, thereby blocking the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells.
Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response.
The US Food and Drug Administration expanded the approval of Yervoyto include pediatric patients 12 years and older in July 2017.
Bristol-Myers Squibb is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients. The company's differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide. The company offers chemically-synthesized drug and biologic in various therapeutic areas, such as oncology; cardiovascular; immunoscience; and virology comprising human immunodeficiency virus infection (HIV).