Dr Sharman's Idelalisib (Zydelig) Update based on European experience

Dr Sharman's Idelalisib (Zydelig) Update based on European experience

There's been some concern on the FDA requirement for a black box warning on the use of Zydelig/idelasilib in the treatment of CLL while Imbrivica/Ibrutinib doesn't have one. But as doctor Sharman states in his latest blog - "A funny thing happened when the Europeans evaluated the same trial data that led to the approval of idelalisib in the US. They saw things differently....



The US FDA and the European Commission on Medicinal Products look at new drugs independently. They look at all the safety of all the clinical trials and the efficacy and come to their own conclusions about when such a drug could / should be used." More at:


See also European Commission Grants Marketing Authorization for Gilead’s Zydelig® (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia:


How refreshing to read "I think the additional insight provided by our European colleagues shed new perspective on how and where we might think to use the drugs here in the US."

Dr Brian Koffman previously commented on the black box warning label for Zydelig (CAL 101 or GS 1101 or idelasilib) on his blog here:



Photo: A white cedar showing its Autumn colours against an evergreen eucalyptus. Sometimes you can learn from contrasts...

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2 Replies

  • Dear Neil

    My head judge can't cope with all this info at the moment.....can you please tell me what this all means in terms of getting thIS treatment on the NHS in the UK. I.E. are we any closer to getting it or similar?



  • Hi Spiller.

    Other UK based community members would be in a far better position to have a feel for what this means with regards to having Zydelig/Idelalisib available on the NHS. I suspect that it will slightly improve its chances from a technical perspective, but that the major barrier will remain the cost. I would hope that this decision will provide some competitive pressure on Imbruvica/Ibrutinib to lower the asking price in European countries for that drug, but is that just wishful thinking on my part? Only time will tell.


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