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FDA Approves Opdivo for Additional Indications

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Opdivo approved for additional indications

Opdivo is one of Bristol-Myers Squibb’s (BMY) recent oncology drugs, already approved by the FDA for the treatment of patients with melanoma, a type of skin cancer, and advanced NSCLC (non-small cell lung cancer). It is meant for patients who have already been treated by platinum-based chemotherapy but have had the disease progress after the chemotherapy.

Opdivo has now been approved by the FDA for the treatment of patients with advanced RCC (renal cell carcinoma), and for the treatment of BRAF WT (wild-type) advanced melanoma.

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Approval for renal cell carcinoma

On November 23, 2015, the FDA approved Opdivo for the treatment of advanced RCC. According to the company’s press release, this injection is approved for the treatment of patients who have already undergone anti-angiogenic therapy. Nearly 90% of total kidney cancer cases are renal cell carcinoma, which accounts for over 100,000 deaths worldwide every year.

Approval for BRAF WT advanced melanoma

On November 24, 2015, FDA approved Opdivo for the treatment of patients with BRAF WT melanoma. Opdivo is approved for the treatment of patients with BRAF WT unresectable or metastatic melanoma. This injection has shown improved overall survival for newly diagnosed patients with these types of melanoma.

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What is Opdivo?

Opdivo, also called nivolumab, is a human programmed cell death protein 1 (PD-1) blocking antibody. This drug reduces tumor growth by blocking the interaction between PD-1 and its ligands.

Opdivo is a part of Bristol-Myers Squibb’s alliance with Ono Pharmaceutical. It is the seventh drug approved by the FDA for the treatment of patients with melanoma. The company is conducting various CheckMate trials to investigate Opdivo’s use in anti-cancer treatments.

Opdivo, one of Bristol-Myers Squibb’s most important products, is expected to be one of the company’s major revenue contributors in the next five years.

Opdivo in global markets

Lung cancer is an important focus in the US markets for all pharmaceutical companies. For European markets, the drug Opdivo was approved by the European Commission in June 2015, as announced by the company’s press release. This makes Opdivo the one and only PD-1 inhibitor that is approved for first-line as well as second-line treatment of advanced melanoma patients in Europe.

Opdivo competes with drugs such as Pfizer’s (PFE) Inylta and Sutent, Bayer’s Nexavar, Merck’s (MRK) Keytruda, GlaxoSmithKline’s (GSK) Mekinist and Tafinlar, and Roche’s Zelboraf. Investors can consider ETFs such as the iShares US Pharmaceuticals ETF (IHE), which holds ~7.6% of its total investments in Bristol-Myers Squibb.

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