I. Introduction to product submission Submission details Type of submission: New chemical entity Decision: Approved Date of decision: 15 December 2016 Date of onto ARTG 5 January 2017 Active ingredient(s): Venetoclax Product name(s): Venclexta Sponsor’s name and address: AbbVie Pty Ltd 241 O’Riordan St, Mascott NSW 2020 Dose form(s): Film-coated tablets 10 mg, 50 mg and 100 mg Strength(s): Container(s): Plastic bottles and blister trays (with plug-assist) Pack size(s): Starter pack for up-titration 1 (14 times 10 mg tablets), –week week 2 (7 times 50 mg tablets), week 3 (7 times 100 mg tablets), and week 4 (14 times 100 mg tablets) The 100mg tablet strength is supplied as a blister pack (112 tablets) and in HDPE bottles (120 tablets) Approved therapeutic use: Venclexta is indicated for the treatment of: patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options. Note to indications. The indications are approved based on overall response rates. Duration of response and improvements in overall survival. of administration: Oral (PO) Dosage: The starting dose of Venclexta is 20 mg once daily for 7 days. The Venclexta dose must be administered according to a weekly dose titration schedule to the recommended daily dose of 400 mg over a period of 5 weeks as shown in Table 6. [see Attachment 1 PI]. The 5-week dose titration schedule is designed to gradually reduce tumour burden (debulking) and decrease the risk of TLS.
I. Introduction to product submission Submission details Type of submission: New chemical entity Decision: Approved Date of decision: 15 December 2016 Date of onto ARTG 5 January 2017 Active ingredient(s): Venetoclax Product name(s): Venclexta Sponsor’s name and address: AbbVie Pty Ltd 241 O’Riordan St, Mascott NSW 2020 Dose form(s): Film-coated tablets Strength(s): 10 mg, 50 mg and 100 mg Container(s): Plastic bottles and blister trays (with plug-assist) Pack size(s): Starter pack for up-titration –week 1 (14 times 10 mg tablets), week 2 (7 times 50 mg tablets), week 3 (7 times 100 mg tablets), and week 4 (14 times 100 mg tablets) The 100mg tablet strength is supplied as a blister pack (112 tablets) and in HDPE bottles (120 tablets) Approved therapeutic use: Venclexta is indicated for the treatment of: patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options. Note to indications. The indications are approved based on overall response rates. Duration of response and improvements in overall survival. of administration: Oral (PO) Dosage: The starting dose of Venclexta is 20 mg once daily for 7 days. The Venclexta dose must be administered according to a weekly dose titration schedule to the recommended daily dose of 400 mg over a period of 5 weeks as shown in Table 6. [see Attachment 1 PI]. The 5-week dose titration schedule is designed to gradually reduce tumour burden (debulking) and decrease the risk of TLS.
auspar-venetoclax-171109.docx