The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb's (BMS) Opdivo (nivolumab) plus Yervoy (ipilimumab) combination for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) in Great Britain.
This immunotherapy combination is the first treatment option approved for patients in the UK for more than 15 years, BMS said in a statement.
Pleural mesothelioma is an uncommon cancer that develops in the layers of tissue covering the lungs. Exposure to asbestos in the workplace is responsible for over 80% of cases of MPM, with disease symptoms often appearing up to 30-50 years after exposure.
Approximately 2,700 people are diagnosed with mesothelioma in the UK annually. The condition is frequently diagnosed at an advanced stage, with an expected lifespan of less than a year if untreated.
Dr Sanjay Popat, consultant thoracic medical oncologist, Royal Marsden Hospital, said: “The approval of nivolumab plus ipilimumab is the first drug approval for mesothelioma since 2004 and will potentially improve survival expectations in these patients.”
The MHRA decision is supported by data from the ongoing Phase III Checkmate -743 study, in which the combination of Opdivo plus Yervoy provided a significant improvement in overall survival (OS) versus standard of care pemetrexed and cisplatin or carboplatin chemotherapy.
At two years, 41% of patients treated with Opdivo plus Yervoy were alive, compared to 27% of patients treated with chemotherapy. Grade 3–4 treatment-related adverse events were experienced by 30% of patients treated with nivolumab plus ipilimumab versus 32% of patients treated with chemotherapy.
The MHRA's positive decision closely follows the European Medicines Agency’s (EMA) approval of the immunotherapy combination in the same indication in June 2021.