European Commission Approves Zydelig for CLL and FL

The European Commission has granted marketing authorization for Zydelig (idelalisib) in the treatment of both chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).

Zydelig is a 150 mg tablet and first-in-class oral treatment for these cancers. The product by Gilead Sciences is licensed for use in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, or as front-line treatment for CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

It has further been licensed as a monotherapy for the treatment of adult patients with FL refractory to two prior lines of treatment. Zydelig inhibits PI3K delta, a protein overexpressed in many B-cell cancers and that plays a role in the viability, proliferation and migration of these cancer cells.

Zydelig is now immediately available for eligible patients with relapsed CLL in England.

Both CLL and FL are indolent and largely considered to be incurable diseases. They can lead to complications including serious infection and bone marrow failure requiring treatment.

An estimated 19,400 new cases of CLL will be diagnosed in France, Germany, Spain, Italy and the UK this year and there are an estimated 112,000 patients currently living with FL.

Zydelig is designed not to cure these patients but to improve overall survival and quality of life.

Source: MNT