Bristol-Myers Squibb recently received two Food and Drug Administration approvals to expand the use of a new type of cancer treatment.

The Food and Drug Administration approved Opdivo to treat a type of kidney cancer. The next day, the same drug was approved to treat an advanced skin cancer.

The decision was supported by data from the Phase III CheckMate-066 trial. The trial showed that Opdivo was superior in overall survival compared with dacarbazine, in the first-line of treatment of patients with unresectable or metastatic BRAF wild-type advanced melanoma.

This is the sixth approval this year for Opdivo. Opdivo is an injection that helps the immune system fight cancer cells. This immunocology drug is a programmed drug receptor blocking antibody.

Immunotherapies work to attack cancer cells using the body’s own immune system. In contrast, chemotherapy and radiation kill both cancerous and healthy cells.

Opdivo was originally approved in December to treat metastatic melanoma in patients that had already had treatment. During that approval, it was granted accelerated approval.

Opdivo is also approved to treat lung cancer and patients with advanced melanoma that have received treatment.

Opdivo was also approved in the United States for the treatment of metastatic renal cell carcinoma in patients who received a certain type of prior therapy.

Sales of Opdivo have reached $467 million in the first nine months of the year, with a majority of the sale occurring in the first three months. Analysists estimate that this drug will eventually generate combined annual revenue in excess of $20 billion by 2020.

Bristol-Myers Squibb is currently still performing clinical trials to see if there are more tumor types that Opdivo can treat.

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Gerry Oginski
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