BERLIN, Jan 5 (APM) - Gilead's Zydelig (idelalisib) showed no added benefit in chronic lymphocytic leukaemia (CLL) or follicular lymphoma, and its dossier lacked the data crucial to making any determination in favour of the drug at all, Germany's IQWiG ruled.

The U.S. pharma's dossier had no data for "any of the indications or therapy situations" where Zydelig could be used, according to a late Friday statement from Germany's second highest health technology assessment (HTA) authority.

Zydelig is authorised in follicular lymphoma deemed refractory after two therapies have failed, and in refractory CLL in second-line, or in recurrent CLL. Zydelig is also indicated for CLL in first line, should chemotherapy not be possible to due to the existence of specific genetic characteristics such as a TP53 mutation.

It was to be compared with best supportive care (BSC) in refractory follicular lymphoma, while five different therapy situations for the drug in CLL were determined by Germany's highest HTA, the G-BA.

Zydelig in first line, in recurrent and in refractory CLL was to be compared with BSC, where further chemotherapy or antineoplastic drugs have been ruled out. For recurrent CLL where further chemotherapy is possible, Zydelig should be compared with chemotherapy and Roche's MabThera (rituximab). Finally, Zydelig was to be compared with individually optimised therapy for refractory CLL where antineoplastic drugs may be taken.

However, Gilead did not follow the conditions for comparators put forward by the G-BA, said the IQWiG. For two therapeutic situations - recurrent CLL where chemotherapy is not an option and refractory CLL where antineoplastic drugs may be taken - the pharma submitted data from a study where Zydelig plus MabThera was compared with MabThera combined with a placebo.

It was therefore not "discernible," whether study participants received individually optimised therapy. In addition, MabThera was used in the comparator arm as a monotherapy, contrary to the drug's label.
For refractory follicular lymphoma, Gilead submitted data from single-arm studies and did not appropriately consider the comparator therapy.

"An added benefit from Zydelig in any of the indications or therapy situations put forward by the G-BA is therefore not proven," the institute concluded.

IQWiG's assessment will now feed into the evaluation conducted by the G-BA, for a final decision which will become the basis for pricing negotiations between the payer and Gilead.

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