Change to section

Details of change

10. DATE OF THE REVISION OF THE TEXT

18 September 2017

Change to section

Details of change

4.8          Undesirable effects

Inclusion of pooled safety data from the pivotal, Phase 3, global C16010 study (n=720) and the double-blind, placebo-controlled C16010 China Continuation Study (n=115).

AND

The frequency of the following adverse reactions has been reclassified:

Herpes zoster – common (≥ 1/100 to < 1/10)

Vomiting - uncommon (≥ 1/1,000 to < 1/100).

Updates to the paragraphs relating to thrombocytopenia, rash, peripheral neuropathy, eye disorders, other adverse reactions.

5.1       Pharmacodynamic properties

A randomized, double-blind, placebo-controlled Phase 3 study was conducted in China (N=115) with a similar study design and eligibility criteria. Many of the patients enrolled in the study had advanced disease with Durie-Salmon Stage III (69%) at initial diagnosis and a treatment history of receiving at least 2 prior therapies (60%) and being thalidomide refractory (63%). At the primary analysis (median follow up of 8 months and a median of 6 cycles), the median PFS was 6.7 months in the NINLARO regimen compared to 4 months in the placebo regimen (p-value=0.035, HR=0.60). At the final analysis for OS at a median follow up of 19.8 months, OS was improved for patients treated in the ixazomib regimen compared with placebo the median OS was improved by 10 months (25.8 months in the NINLARO regimen and 15.8 months in the placebo regimen [p-value=0.0014, HR=0.42, 95% CI: 0.242, 0.726 ]).

10.      DATE OF REVISION OF THE TEXT

6 July 2017