Australian women with HR+ HER2- metastatic breast cancer gain broad access to CDK4/6 inhibitor Kisqali and Fulvestant Sandoz

· Kisqali becomes the first CDK4/6 inhibitor, in combination with Fulvestrant Sandoz, listed on the PBS for women newly diagnosed with advanced or metastatic breast cancer and for those whose disease has progressed on standard endocrine therapy

· Reimbursement of Kisqali and Fulvestrant Sandoz addresses an important unmet need for women with metastatic breast cancer

Sydney, March 28^th, 2021 — The Honorable Greg Hunt, Minister for Health, today announced that as of April 1, Kisqali will become the first CDK 4/6 inhibitor to be listed on the Pharmaceutical Benefits Scheme (PBS), together with Fulvestrant Sandoz^®, for women with HR+ HER2- metastatic breast cancer. This combination is reimbursed for those who are newly diagnosed with metastatic breast cancer, as well as for those previously treated with endocrine therapy.

It's estimated 20,000 Australians will be newly diagnosed with breast cancer in 2021 – and one in five of these will go on to have metastatic or advanced disease.¹

All women living with HR+ HER2- metastatic breast cancer, regardless of age or previous treatment, will now be able to access the Kisqali and Fulvestrant Sandoz combination via the PBS – addressing a significant unmet need within the community by expanding access to the latest advances in treatment.²Dr. Jodi Lynch, Medical Oncologist, Specialising in Breast and Gynaecologcal Malignancies said: "This is the first reimbursed and more broadly available CDK4/6 inhibitor in combination with Fulvestrant, creating more options for eligible patients across Australia".

Kirsten Pilatti, Chief Executive Officer, Breast Cancer Network Australia (BCNA) welcomed the news stating: "This is an important day in ensuring we're delivering the best possible treatments to all Australians living with metastatic breast cancer. The PBS listing is another step closer to making sure Australia doesn't have a two-tiered system where only those who can afford it can access the best care. Being able to provide quality drugs that may help women or men living with metastatic breast cancer live longer, means the world, not only to the patient, but to their family and friends."

Cheryl Maley, General Manager Novartis Oncology, ANZ said "Novartis has a proud heritage in developing and providing access to innovative breast cancer treatments and we are thrilled with todays announcement. We recognise the difference this announcement will make to hundreds of patients across Australia and thank the Australian Government in providing broad, equitable access for these patients."