The recommendation to the EMA came soon after Zydiga (idelalisib) was approved in the US.
Close on the heels of the oncology drug Zydelig (idelalisib 150 mg) gaining approval in the U.S., Gilead Sciences (GILD Analyst Report) announced that the drug has been recommended for approval in the EU by the European Medicines Agency's (EMA) 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) 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 Analyst Report)/ 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.
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