European CHMP Adopts Positive Opinion for Yescarta (axicabtagene ciloleucel)

- June 29th, 2018

Kite, a Gilead Company (Nasdaq:GILD), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application (MAA) for Yescarta (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell … Continued

Kite, a Gilead Company (Nasdaq:GILD), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application (MAA) for Yescarta (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

As quoted in the press release:

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy that modifies a patient’s own T cells to recognize and attack cancer cells and has the potential to induce complete responses (no detectable cancer) in a proportion of patients with aggressive forms of non-Hodgkin lymphoma (NHL). Axicabtagene ciloleucel was granted PRIME status by the EMA in May 2016.

The CHMP positive opinion was adopted following review by European Union (EU) regulators, including the Committee for Advanced Therapies and the CHMP. The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the EU, Norway, Iceland and Liechtenstein.

“This CHMP positive opinion is an important milestone for those patients in the European Union living with DLBCL or PMBCL,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “The recommendation brings axicabtagene ciloleucel one step closer to adult patients who currently have few or no treatment options available to them and we are focused on providing access to this innovative treatment as quickly as possible.”

Click here to read the full press release.

 

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