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Home Industry News Gilead Sciences receives CHMP backing for Zydelig approval

Gilead Sciences receives CHMP backing for Zydelig approval

28th July 2014

Gilead Sciences has announced that its new cancer therapy Zydelig has been recommended for approval in Europe.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the company's marketing authorisation application for the first-in-class treatment, improving its prospects of final approval by the European Commission.

Zydelig has demonstrated its safety and efficacy in the treatment of chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL) – the most common subtype of indolent non-Hodgkin lymphoma – in two pivotal clinical trials.

The drug is intended for use in combination with rituximab for adult patients with CLL who have received at least one prior therapy, or as first-line treatment in CLL patients unsuitable for chemo-immunotherapy in the presence of 17p deletion or TP53 mutation.

It can also be used as a monotherapy for adult patients with FL that has proven refractory to two prior lines of treatment.

Earlier this month, Gilead revealed that it will be working with the Medicines Patent Pool to expand access to its new HIV and hepatitis B therapy tenofovir alafenamide in developing nations around the world.ADNFCR-8000103-ID-801737937-ADNFCR

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