The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorisation Application (MAA) for Zydelig (idelalisib 150mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma.
The CHMP opinion supports the MAA for the use of idelalisib in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to licence medicines for use in the 28 countries of the European Union (EU).
CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anaemia, serious infection and bone marrow failure requiring treatment. Relapse commonly occurs after initial chemo-immunotherapy and many patients with relapsed CLL or FL are unable to tolerate chemotherapy, which may limit their treatment options.
The CHMP positive opinion for idelalisib is based on data from two clinical trials - Study 116 and 101-09. Study 116, a pivotal Phase 3 trial, investigated the efficacy and safety of idelalisib in combination with rituximab in patients with previously treated CLL. The Phase 2 101-09 study assessed the efficacy and safety of idelalisib in patients with iNHL who are refractory to rituximab and alkylating agents. Results of Study 116 and Study 101-09 were published in The New England Journal of Medicine in March 2014.
Idelalisib is an investigational product and its safety and efficacy have not been established.