New melanoma drug approved by FDA
pharmafile | March 28, 2011 | News story | Sales and Marketing | BMS, melanoma
Yervoy, Bristol Myers Squibb’s new treatment for advanced skin cancer has gained approval in the US.
The drug is the first melanoma treatment to increase overall survival, and could be a major step forward in treating the disease – but it also carries a risk of very serious side-effects.
Yervoy (ipilimumab) has been approved as a first and second line treatment for advanced, inoperable or metastatic melanoma, the deadliest and most aggressive form of skin cancer.
Analysts forecasts for the drug range from $820 million (£513 million) to $1.7 billion by 2015.
The approval was based on impressive phase III results in which Yervoy (ipilimumab) increased median overall survival, the gold standard in oncology trials, by 10 months, compared with just over six months when compared to GP-100.
GP-100 is an investigational cancer vaccine under phase II trials by the National Cancer Institute, but has so far only shown an increase in progression free survival in its own clinical studies.
Richard Pazdur, director at the FDA, said: “Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life.
“Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment,” he said.
BMS said its drug is given in a 90-minute infusion every three weeks for a total of four doses, costing $120,000 for a full course of treatment.
This will become one of the most expensive drugs on the US market, with its price higher than Dendreon’s controversial $90,000 price tag for its novel prostate cancer vaccine Provenge.
Black box warning
The drug had received fast-track status in 2010 but the FDA delayed its decision until this March as it required more information on the drug’s safety profile.
The FDA has issued a ‘black box’ warning on the drug after severe to fatal autoimmune reactions were seen in 13% of patients treated with Yervoy.
These included enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.
Due to the unusual and severe side effects associated with Yervoy, the FDA has approved the drug alongside a Risk Evaluation and Mitigation Strategy to inform healthcare professionals about these serious risks.
A medication guide will also be provided to patients to inform them about the therapy’s potential side effects.
Yervoy steals march over rivals
There are an estimated 40,000 deaths worldwide from melanoma, with the number of cases in developed countries predicted to double, from 138,000 a year to 227,000 by 2019.
Such high rates of skin cancer makes it a potentially lucrative market for pharma and BMS has stolen a march over its rivals by being the first of the new melanoma drugs to make it to market.
These rivals include Roche that is currently developing RG7204 as a first line treatment for advanced BRAF V600 melanoma, with its most recent phase III trial extending progression-free survival and overall survival.
GlaxoSmithKline has recently started late-stage trials of two new drugs for advanced or metastatic melanoma patients who are also expressing the BRAF V600 mutation, with top line results expected later this year.
Yervoy is a monoclonal antibody that blocks a molecule known as cytotoxic T-lymphocyte antigen or CTLA-4. CTLA-4 that may play a role in slowing down or turning off the body’s immune system, affecting its ability to fight off cancerous cells.
BMS says its drug may work by allowing the body’s immune system to recognise, target, and attack cells in melanoma tumours.
In addition to melanoma, BMS is also testing its drug against advanced prostate cancer in phase III trials and also plans to begin a final-stage trial in lung cancer this year.
Yervoy is still under review by Europe’s regulator the EMA, which received BMS’s submission last July.
Ben Adams
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