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US FDA approves new indication for Bristol-Myers' Opdivo in treating melanoma

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US FDA approves new indication for Bristol-Myers' Opdivo in treating melanoma

U.S. Food and Drug Administration approved Bristol-Myers Squibb Co.'s Opdivo as a post surgical treatment for a type of melanoma.

Opdivo was approved for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

The purpose of adjuvant therapy is to reduce the risk of recurrence following surgical removal of the tumor and lymph nodes that contain cancer.

The approval was based on a phase 3 study, which showed that Opdivo lowered the risk of the disease recurring by 35% as compared to Yervoy, another Bristol-Myers drug. After 18 months, about 66.4% of those treated with Opdivo did not have any recurrence of the disease, while 52.7% of those treated Yervoy remained disease free.

About three in every 10 patients with stage 3 melanoma receive adjuvant therapy after surgery, with a majority of stage 3B and 3C melanoma patients experiencing disease recurrence within five years.