Roche’s melanoma treatment drug Zelboraf receives FDA Approval

WASHINGTON (AP) — The United States Food and Drug Administration has approved the first and one-of-a-kind drug manufactured by Roche that is intended to combat the worst form of skin cancer.

The drug Zelboraf is the first treatment for melanoma and targets a specific gene mutation occuring in nearly 50% of patients with skin-cancer tumors. The agency also declared that it provided approval and consent for an investigation that monitors these mutations in patients.

Based on new diagnoses, Melanoma has been found to be the most rapidly growing form of cancer. The accelerated tumor spread has been credited to longer life expectancies in the aged and higher indoor tanning in the young.
Stats by the American Cancer Society reveal that nearly 68,000 Americans were diagnosed last year and 8,700 succumbed to the disease.

For decades, Melanoma has been implicated as one of the most difficult cancers with limited medication options for treatment. In March, the FDA approved a drug by Bristol-Myers Squibb that demonstrated extended survival rates in advanced skin cancer patients.

Melanoma patients produce a mutated form of protein called BRAF, which when healthy assists in cell growth. Zelboraf is said to provide a second treatment option for these patients, as it acts by restricting the mutated protein thereby retarding tumor growth.

The ongoing study involves 675 patients who are assigned to one of the two study arms: either Zelboraf or a chemotherapy drug. FDA data reveals that 77% people administered Zelboraf are still alive in contrast with 64% people who were administered the older drug.

Irrespective of the higher survival rate, patients administered Zelboraf experienced tumor re-growth after 7 months of therapy because melanoma acclimatizes very rapidly. The survival rate with both the drugs has not yet been compared and established.

Nearly $56,400 is the expected treatment cost for a six-month course with Zelboraf.

Skin rashes, joint pain, fatigue, diarrhea, and hair loss are the most likely drug side effects, and nearly 26% patients progress to develop a less deadly form of skin cancer.

The FDA completed its drug review far ahead of the anticipated target of Oct. 28, and melanoma patient advocates were all praises for the agency that facilitated expedited drug clearance.

In a statement, the director of the Melanoma Research Foundation, Timothy Turnham said, “The FDA’s quick action on this drug approval is important because it gives melanoma patients a new way to fight this deadly disease.”

Roche’s Genentech offered to conduct a study in June to learn about the combined effects of Zelboraf in and Yervoy, the only other melanoma drug by Bristol-Myers known to prolong survival.

Roche’s South San Francisco, Calif. based Genentech unit and Japanese drugmaker, Daiichi Sankyo jointly developed Zelboraf and are expected to co-market the drug in the U.S.

Earlier on Wednesday, Roche declared that Zelboraf would hit the markets within two weeks.

The European regulatory agency as well as half-dozen other regulatory authorities around the world are reviewing the drug.