A breakthrough drug that could extend survival in some patients with advanced skin cancer was approved on Wednesday by US regulators, offering the first new treatment for melanoma in 13 years.

Zelboraf was given the nod by the US Food and Drug Administration more than two months early, after a global clinical trial showed it could work better than chemotherapy by targeting a gene mutation found in about half of patients.

While the drug, made by Genentech, a US subsidiary of the Swiss pharmaceutical giant Roche, is far from a cure for people with metastatic melanoma, its approval was hailed as “a really big deal” by research advocates.

Zelboraf (vemurafenib) is the second melanoma drug to obtain approval this year, following Yervoy (ipilimumab) in March.

The treatment only works in patients with advanced melanoma whose tumours express a gene mutation called BRAF V600E, meaning it could help about 10,000 patients in the US, according to experts. Just a few treatments for melanoma currently exist, with little success in extending the life of patients. Most people diagnosed with advanced melanoma die within 11 months, said Tim Turnham of the Melanoma Research Foundation.

“This is a really big deal,” Dr Turnham said. “This is two drugs after 13 years of nothing.” Zelboraf works by blocking a protein that is involved with cell growth.

“This is a whole new approach to tackling melanoma,” explained Turnham. “This actually goes into the malignant tumour cells and shuts them down.”

The FDA said the approval of Zelboraf comes with a diagnostic test called the cobas 4800 BRAF V600 mutation test to determine if patients have the type of cancer that the drug can treat.

“Today’s approval of Zelboraf and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Centre for Devices and Radiological Health.

Sign up to our free newsletters

Get the best updates straight to your inbox:
Please select at least one mailing list.

You can unsubscribe at any time by clicking the link in the footer of our emails. We use Mailchimp as our marketing platform. By subscribing, you acknowledge that your information will be transferred to Mailchimp for processing.