Roche Holding has filed vemurafenib for approval in Europe and the United States to treat the deadliest form of skin cancer, the Swiss drugmaker said, underscoring the strength of its oncology pipeline.

The news came after Roche, the world's largest maker of cancer drugs, saw a number of setbacks to its pipeline last year, rattling investors.

Roche had previously said it was aiming to file the medicine, which it has been developing with privately held Plexxikon, for approval in the second half and was hoping to launch the drug late next year or in early 2013.

Analysts have estimated it will have peak sales of 500 million Swiss francs ($520 million) to 1 billion.

Melanoma is the deadliest form of skin cancer. Once it returns and spreads after initial treatment there are virtually no effective alternative treatments available.

The Roche/Plexxikon drug and ipilimumab, an experimental drug for advanced melanoma being developed by U.S. group Bristol-Myers Squibb, are providing the possibility of hope for patients who have previously had few options.

The submissions for people with BRAF V600 mutation-positive metastatic melanoma are based on two studies, Roche said.

The BRIM3 trial showed the drug helps patients live longer and also extends the period in which their disease does not get worse compared to those taking dacarbazine, the current standard of care, while the BRIM2 trial showed vemurafenib shrank tumours in 52 per cent of trial participants.

Full data from the BRIM3 study and updated data from the BRIM2 trial will be presented at the annual meeting of the American Society of Clinical Oncology next month.

Reuters