EMA Validates Opdivo’s Application for Additional Indications


Mar. 31 2016, Published 5:24 p.m. ET

Opdivo application validated for additional indications

Opdivo is one of the recent oncology drugs from Bristol-Myers Squibb (BMY), already approved by the FDA and European Medicines Agency (or EMA) for the treatment of patients with melanoma, a type of skin cancer.

Opdivo is also approved to treat advanced non-small cell lung cancer (or NSCLC) for patients who are already treated with platinum-based chemotherapy, but that the disease has progressed after the chemotherapy.

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On March 30, 2016, EMA validated the type-II variation application for extending the current indications for Opdivo. According to this application, Bristol-Myers Squibb seeks approval of Opdivo for use in the treatment of patients with classical Hodgkin lymphoma (or cHL) after the failure of autologous hematopoietic stem cell transplant and brentuximab vedotin treatment.

The validation of this application implies that the submission of the drug for approval for a specific treatment is complete. The European Medicines Agency will begin the review process for that drug.

What is Hodgkin’s lymphoma?

Hodgkin’s lymphoma, one of two main types of lymphoma, is cancer beginning in the lymph nodes. It is characterized by malignant lymphocytes called Reed-Sternberg cells. The second type of lymphoma, termed non-Hodgkin’s lymphoma, is much more common as compared to Hodgkin’s lymphoma.

According to the company’s press release, there are around 12,200 new cases and 2,600 deaths expected each year in the European Union.

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Studies supporting Opdivo’s application

In this application, the data from Opdivo’s Checkmate-205 study was included. The Checkmate-205 study evaluated the use of Opdivo for patients with classical Hodgkin’s lymphoma (or cHL) after the failure of autologous stem cell transplant and brentuximab vedotin treatment.

Brentuximab vedotin is an international nonproprietary name for Seattle Genetics’ (SGEN) drug Adcetris used for the treatment of Classical Hodgkin’s Lymphoma and systemic anaplastic large cell lymphoma.

Opdivo competes with drugs like Pfizer’s (PFE) Inylta and Sutent, Bayer Pharma’s Nexavar, Merck’s (MRK) Keytruda, GlaxoSmithKline’s (GSK) Mekinist and Tafinlar, and Roche’s Zelboraf.

Investors can consider ETFs like the iShares US Pharmaceuticals ETF (IHE) which holds ~7.0% of its total assets in Bristol-Myers Squibb. Investors can also consider the Dynamic Large Cap Growth Intellidex Index (PWB), which holds 3.3% of its total assets in Bristol-Myers Squibb, in order to diffuse the risk.


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