Gilead's Oncology Drug Recommended for Approval in the EU


Close on the heels of the oncology drug Zydelig (idelalisib 150 mg) gaining approval in the U.S., Gilead Sciences (GILD) announced that the drug has been recommended for approval in the EU by the European Medicines Agency's (EMA.TO) Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended the approval of the drug for treating adults suffering from chronic lymphocytic leukemia (CLL.TO) and follicular lymphoma (FL). The favorable opinion from the CHMP will now be reviewed by the European Commission with a final decision expected in the next couple of months.

In particular, the CHMP is in favor of the EU approval of Zydelig in combination with Roche/ Biogen Idec’s (RHHBY/BIIB) Rituxan for treating CLL patients who have received at least one prior therapy or as a first-line treatment in CLL patients unsuitable for chemotherapy due to a genetic mutation. The CHMP has also recommended approving the drug as a monotherapy for treating FL patients who have not responded to two prior therapies.

The CHMP’s favorable opinion is based on encouraging results on Zydelig from two studies —116 (phase III) and 101-09 (phase II). We note that Zydelig was approved in the U.S. last week for treating three forms of blood cancer — CLL (in combination with Rituxan), FL and small lymphocytic lymphoma.  

However, the approval came with a black box warning about the risk of severe toxicities. The drug was approved with a Risk Evaluation and Mitigation Strategy to make the doctors and patients aware of the risks associated with the drug’s usage.

We believe that investor focus will remain primarily on Gilead’s hepatitis C virus drug Sovaldi. The drug has recorded sales of approximately $5.8 billion in the first six months of 2014. The treatment is expected to continue its strong performance through 2014.

Gilead currently carries a Zacks Rank #3 (Hold). A better ranked stock in the healthcare space is Salix Pharmaceuticals (SLXP) with a Zacks Rank # 1 (Strong Buy).

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