A Roche Holding AG experimental medicine, which the Swiss drugmaker is developing with Plexxikon Inc., extended the lives of patients with the deadliest and most aggressive form of skin cancer in a study.
The trial, from the last of three phases usually needed for regulatory approval, included patients who suffered from previously untreated cancer that had spread, the company said today in a statement.
The drug known as PLX4032, which is effective in patients who carry a gene mutation called BRAF V600, let patients live longer and curbed the growth of the cancer, Basel, Switzerland-based Roche said. About 40,000 people die from the disease each year, and the number of patients with metastatic melanoma is expected to double to 227,000 from 138,000 new cases annually by 2019 in developed countries.
“This is an important advance for people with the BRAF V600 mutation-positive form of the disease who have had extremely limited treatment options,” Roche’s head of global product development, Hal Barron, said in the statement.
People are usually expected to live less than one year after diagnosis. Patients in the control group of the study will be offered the drug, Roche said, and the company is working with regulators to give patients early access to PLX4032.
Serious side effects were a more common and treatable skin cancer and changes in the levels of liver enzymes. The most common side effects were rash, light sensitivity, joint pain, hair loss and fatigue.
PLX4032 is also known as RG7204.