The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly.
The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma.
In March 2014, MHRA announced it was launching EAMS, saying it would allow earlier access to potentially lifesaving medicines for patients with severe or life-threatening conditions.
For a product to qualify for EAMS, it must be granted a promising innovative medicine (PIM) designation based on early (Phase I and/or II) clinical data and satisfy additional criteria including the severity of the condition the product is intended to treat and the level of improvement over previously authorized treatments.
Since EAMS approval is based on early clinical data, companies are required to provide MHRA with regular reports documenting patient exposure and adverse effects, and should notify the agency of changes to treatment protocols based on data gathered through the product's use.
Because these products are not yet licensed in the UK, MHRA says a positive EAMS assessment is intended to "inform doctors who may wish to prescribe the unlicensed medicine under their own responsibility," such as in cases where other options have been exhausted. Additionally, MHRA says that a positive EAMS assessment should not be considered to be an indication of future authorization of a product.
Early Adopters: Cancer Therapies
Thus far, Opdivo and Keytruda are the only two products that have been given a positive EAMS opinion.
While EAMS is still in its infancy, the positive assessment of two advanced melanoma drugs could be an indication that both drugmakers and MHRA will look to EAMS as a means of accelerating patient access for cancer treatments.
Many cancers still lack effective treatment, and due to the deadly and pressing nature of the disease, patients and their physicians may be willing to accept greater risk by undergoing treatments that are not licensed.
In the case of Opdivo, MHRA says its positive assessment is based on promising patient survival data "where other treatments currently have poor results," demonstrated in two early studies. MHRA cautions that there are still many uncertainties about long-term survival, and says studies are still being conducted on the drug.
Both Opdivo and Keytruda have been recommended for authorization by the European Medicines Agency (EMA), but await authorization by the European Commission (EC), which will decide whether or not to adopt EMA's recommendations. If authorized, both drugs would become licensed in the UK through the centralized procedure. However, through EAMS, patients in the UK will be able to access them immediately at the behest of their physician.