European Regulators Recommend New Skin Cancer Treatment
Roche Holding AG’s skin cancer treatment has been recommended for marketing approval from Europe’s Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency said in a statement on Friday.
“There is a high unmet medical need for alternative treatments for metastatic melanoma that improve survival of patients,” the EMA said. About a fourth of people diagnosed with metastatic or unresectable melanoma survive a year after diagnosis, compared with 90 percent of patients with localized melanoma, the agency said.
Zelboraf, which in August was approved for sale in the United States, can be used on metastatic or unresectable melanoma, a form of skin cancer with lower rates of survival than localized melanoma, the European Medicines Agency said in a statement.
The drug is a BRAF-inhibitor that works by blocking a protein that fuels tumor growth in around half of patients with advanced forms of skin cancer, and would potentially treat the 8,300 men and 7,600 women who annually die of the disease Europe, according to the EMA.
Zelboraf can improve overall survival in melanoma patients that have tumors that are positive for BRAFV600E. The general side effects are rash, arthralgia, fatigue, photosensitivity reaction, nausea, alopecia and pruritis, however the committee noted that that “magnitude of risk was likely to be low.”
The Swiss drug maker expects that the EMA endorsement for Zelboraf will be used by the European Commission to formally approve the drug in February.
Melanoma is generally a curable disease when diagnosed early, however it can spread quickly to other parts of the body and is the deadliest and most aggressive form of skin cancer. A patient with metastatic melanoma generally has a short life expectancy which is measured in months. It is a disease that affects people worldwide, and about 48,000 will die annually from the disease, according to the World Health Organization.
"The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options," said Hal Barron, chief medical officer and head, Global Product Development. "We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible."
Zelboraf authorizations are still pending in a number of countries, including Australia, New Zealand, Brazil, India, Canada, and Mexico.