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...