Bristol Myers Squibb's (BMS) Opdualag (nivolumab and relatlimab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat patients aged 12 years and older with advanced melanoma.
The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with around 17,000 cases of the disease diagnosed in the UK every year.
Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses.
The active ingredients in Opdualag, which is administered via a drip over 30 minutes every four weeks, are designed to recognise and attach to a specific target substance in the body, helping patients' immune systems to fight cancer.
The MHRA’s decision on the therapy was supported by results from a phase 2/3 clinical trial of 714 patients with previously untreated advanced melanoma who were randomised to receive a combination of nivolumab and relatlimab or nivolumab alone.
Patients who were given the combination treatment lived for an average of 10.1 months without disease progression, while those receiving nivolumab alone lived for an average of 4.6 months.
The regulatory agency authorised Opdualag through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs, to help patients access treatments more quickly.
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “Project Orbis aims to open access to safe and effective new cancer drugs for patients that need them. As with all products, we will keep the safety of Opdualag under close review.”
The authorisation comes just over two months after the US Food and Drug Administration (FDA) approved nivolumab, sold under the brand name Opdivo, for expanded melanoma use.
The decision made the drug, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma.
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