marketing requirement Treatment of adult patients with CLL who have received at least one prior therapy, or in first line in the 30 Oct 2013 21 Oct 2014 N/A presence of del17p or TP53 mutation in patients unsuitable for WM 12 Nov 2014 pending Imbruvica (ibrutinib) is indicated for the treatment of patients with CLL, including those with del17p, who have received at least one prior therapy, of for the frontline treatment of patients with CLL with del17p. 16 April 2014 17 Nov 2014 N/A Clinical effectiveness of Imbruvica in the frontline setting is trial on the Canada benefit observed in CLL paints with del17p who have received at least one prior therapy. Clinical data in the frontline setting are very limited. MCL who have received at least one 23 Oct 2014 pending prior therapy Treatment of adult patients with N/A, but Phase MCL, characterised by translocation t III Study 10 Nov 2014 (11,14) an/or expression of cyclin D1 10 Jan 2014 (accelerated in whom no partial response (PR) 1 is a approval) was achieved with prior therapy or Switzerland progression after prior therapy requirement Treatment of adult patients with CLL who have received at least one prior 30 Jun 2014 pending therapy Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) Ibrutinib has the following structure as shown in Figure 1. Figure 1: Chemical structure of ibrutinib. Ibrutinib is manufactured by chemical synthesis as a white to off-white solid. It contains one stereocentre and is synthesised as the R configuration. The electrophilic acryloyl group covalently interacts with a cysteine residue in the Btk active site (Cys-481).
marketing requirement Treatment of adult patients with CLL who have received at least one prior therapy, or in first line in the presence of del17p or TP53 mutation in patients unsuitable for 30 Oct 2013 21 Oct 2014 N/A WM 12 Nov 2014 pending Canada Imbruvica (ibrutinib) is indicated for the treatment of patients with CLL, including those with del17p, who have received at least one prior therapy, of for the frontline treatment of patients with CLL with del17p. Clinical effectiveness of Imbruvica in the frontline setting is on the benefit observed in CLL paints with del17p who have received at least one prior therapy. Clinical data in the frontline setting are very limited. 16 April 2014 17 Nov 2014 N/A MCL who have received at least one prior therapy 23 Oct 2014 pending Switzerland Treatment of adult patients with MCL, characterised by translocation t (11,14) an/or expression of cyclin D1 in whom no partial response (PR) was achieved with prior therapy or progression after prior therapy 10 Jan 2014 10 Nov 2014 (accelerated approval) N/A, but Phase III Study is a requirement Treatment of adult patients with CLL who have received at least one prior therapy 30 Jun 2014 pending Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings Drug substance (active ingredient) Ibrutinib has the following structure as shown in Figure 1. Figure 1: Chemical structure of ibrutinib. Ibrutinib is manufactured by chemical synthesis as a white to off-white solid. It contains one stereocentre and is synthesised as the R configuration. The electrophilic acryloyl group covalently interacts with a cysteine residue in the Btk active site (Cys-481). 1 trial
auspar-ibrutinib-160202.docx