Roche’s Zelboraf approved by FDA months ahead of schedule
pharmafile | August 18, 2011 | News story | Sales and Marketing | Yervoy, Zelboraf, skin cancer
The FDA has approved Roche and Daiichi Sankyo’s new skin cancer drug Zelboraf two months ahead of schedule.
Zelboraf (vemurafenib) is now licenced for late-stage metastatic or inoperable melanoma patients who over-express the BRAF V600E mutation, which is present in around half of all melanoma patients.
Hal Barron, head of global product development at Roche, said: “The FDA approval of Zelboraf marks a major step forward in personalising the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options.
“We will continue to study this medicine with a goal of further improving outcomes for people with melanoma and other cancers that are driven by BRAF mutations.”
The FDA has approved the drug more two months ahead its 28 October scheduled deadline because of Zelboraf’s impressive phase III data.
In its latest BRIM3 trial, the risk of death was reduced by 56% for people who received Zelboraf compared to those who received chemotherapy alone.
At the time of the analysis, median overall survival of patients receiving Zelboraf had not been reached, but was 7.9 months for those receiving chemotherapy.
People who received Zelboraf also had a 74% reduced risk of the disease getting worse or dying compared to patients on chemotherapy, with median progression-free survival at 5.3 months for those who received Zelboraf, compared to 1.6 months for the chemotherapy arm.
Roche says the drug will be launched in two weeks in the US, where melanoma is the leading cause of death from skin disease.
The National Cancer Institute estimated that 68,130 new cases of melanoma were diagnosed in the country during 2010, with about 8,700 people dying from the disease.
Personalised treatment
The FDA has also simultaneously approved Roche’s diagnostic tool, the cobas BRAF Mutation Test alongside the drug, which tests for the most appropriate treatment options.
Paul Brown, head of Roche Molecular Systems, said: “The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods.
“With a personalised medicine now available, all people diagnosed with inoperable or metastatic melanoma should be tested to help determine the best options for treatment.”
Previously, Brown said that the cobas test would cost around $150 per patient.
Increasingly competitive market
This is the second late-stage melanoma drug to be approved by the US regulator after it gave the green light to Bristol-Myers Squibb’s cancer vaccine Yervoy (ipilimumab) in March.
Yervoy costs $120,000 per patient for a course of treatment (four doses, one given every three weeks), while Roche’s new drug has to be taken daily at a monthly cost of $9,400.
A company spokesperson told Pharmafocus this means a typical course of treatment with Zelboraf works out at approximately $56,400. This is based on patients taking Zelboraf until disease progression (as per its FDA-approval label), which was a median of 5.3 months in the BRIM3 trial (previously untreated patients) and a median of 6.1 months in BRIM2 (previously treated patients).
Despite the price difference BMS’ Yervoy is expected to make peak annual sales $1.4 billion, nearly double those of Zelboraf, primarily because it has the capacity to treat all late-stage melanoma patients.
Both companies have, however, already started early-stage trials to assess a combination therapy with the two drugs, in order to help treat more patients and to increase uptake.
Side effects
Both drugs come with some serious side effects: during its approval Yervoy received an FDA ‘black box’ warning on the drug after severe to fatal autoimmune reactions were seen in 13% of patients treated with the drug.
These included enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.
Zelboraf also has its fair share of adverse events, including a significantly increased risk of cutaneous squamous cell carcinoma – another form of skin cancer, decreased liver function and joint pain.
The FDA said that the drug was being approved with a Medication Guide to inform health care professionals and patients of Zelboraf’s potential risks.
Ben Adams
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