Posted by Michael Wonder on 02 Jul 2016
Idelalisib in the second-line treatment in CLL: additional benefits still not seen
1 July 2016 - EMA safety review invokes reassessment but still no relevant data.
In 2014, the IQWiG examined whether the use of idelalisib (Zydelig) in certain patients with chronic lymphocytic leukaemia (CLL) offers advantages over the appropriate comparator therapy. An additional clinical benefit was not seen, because its sponsor did not provide appropriate data.
Following reports of serious complications and deaths, mostly due to respiratory infections, the EMA restricted the use of idelalisib in March 2016. Idelalisib should not be used as a new first-line treatment for CLL. It can be used as a second-line agent the agent as the well as the continuation of previously initiated first-line therapy.
The G-BA has comissioned the IQWiG to undertake a reassessment of idelalisib. In the new dossier evaluation, the institute concluded that an additional clinical benefit of idelalisib over the appropriate comparator therapy has not been established.
