PracticeUpdate: Oncology - Winter 2018

TREAT early

First line treatment for HR+, HER2- ABC in men and postmenopausal women in combination with an aromatase inhibitor 1

EXTEND control

NOW PBS LISTED!

Over 2-year median PFS in combination with letrozole 3,4 With 54.7% of patients progression free at 2-years 3 out of 4 patients experienced tumour reduction as early as week 8 in combination with letrozole 5† † subgroup analysis of patients with measurable disease at baseline

REDUCE risk

43.2% reduced risk of progression or death in combination with letrozole 1 Vs. placebo + letrozole at 2-years (HR=0.568, 95% CI: 0.457—0.704, P<0.0001) 1

appetite, headache, insomnia, dyspnoea, back pain, nausea, diarrhoea, vomiting, constipation, stomatitis, abdominal pain, alopecia, rash, pruritus, fatigue, peripheral oedema, asthenia, pyrexia, abnormal LFTs, leukocyte count decreased, neutrophil count decreased, haemoglobin decreased, lymphocyte count decreased, platelet count decreased, ALT increased, AST increased, creatinine increased, phosphorous decreased, potassium decreased. Common (1-10%): thrombocytopenia, febrile neutropenia, lacrimation increased, dry eye, hypocalcaemia, hypokalaemia, hypophosphataemia, syncope, epistaxis, dysgeusia, dyspepsia, hepatotoxicity, erythema, peripheral oedema, weight decreased, ECG QT prolonged, bilirubin increased. Dosage: Adults - Kisqali 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment, in repeating cycles of 28 days. Caution in severe renal impairment and/or moderate or severe hepatic impairment. Kisqali may require dose interruption, reduction, or discontinuation. Safety and efficacy not established in paediatrics, adolescents. Refer to full Kisqali PI and aromatase inhibitor PI. (kis120218m) ABBREVIATIONS: CDK, cyclin dependent kinase; HR+, hormone receptor positive; HER-, human epidermal growth factor receptor negative; ABC, advanced breast cancer; PFS, progression free survival; HR, hazard ratio; CI, confidence interval. REFERENCES: 1. Kisqali Product Information. 2. Pharmaceutical Benefits Scheme. Available at: www.pbs.gov.au. Accessed July 2018. 3. Hortobagyi GN et al. N Engl J Med. 2016;375(18):1738-1748. 4. Hortobagyi GN et al. Poster 1038: ASCO June 2-6, 2017; Chicago, IL. 5. Burris HA et al . Burris HA et al . Poster P4-22-16: SABCS Dec 6-10, 2016; San Antonio, TX.

Novartis Pharmaceuticals Australia Pty Limited ABN 18 004 244 160. 54 Waterloo Road, Macquarie Park NSW 2113. Ph (02) 9805 3555. ® Registered Trademark. Item No: AU-6242. Date of preparation July 2018. 3013RC.