Bristol Myers Squibb’s (BMS) immunotherapy combination Opdivo plus Yervoy has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of certain advanced bowel cancer patients.
In its final appraisal document (FAD), NICE has recommended Opdivo (nivolumab) plus Yervoy (ipilimumab) for advanced bowel cancer patients with the rare high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) mutations following failed fluoropyrimidine-based chemotherapy.
In a statement, BMS said this makes Opdivo plus Yervoy the first immunotherapy combination approved in the UK for these patients.
The approval is based on data from the ongoing Phase II Checkmate-142 study, which showed an objective response rate of 65% for Opdivo plus Yervoy-treated patients after a follow-up of 51 months.
“At Bristol Myers Squibb we are committed to bringing our innovative medicines to patients across the UK and Ireland,” said Hubert Bland, executive medical director UK and Ireland, BMS.
“We are grateful to the hospitals and patients involved in the trials that have helped bring this immunotherapy combination to patients with advanced bowel cancer,” he added.
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Opdivo plus Yervoy in MSI-H/dMMR advanced bowel cancer patients.
Opdivo plus Yervoy also received approval from the US Food and Drug Administration (FDA) in July 2018 for the treatment of adult and paediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following prior chemotherapy treatment.