Ribociclib (Kisqali) in combination with fulvestrant has been PBS-listed for the treatment of patients with HR-positive, HER2-negative unresectable advanced or metastatic breast cancer.
Pivotal studies included the MONALEESA-3 trial which showed overall survival with the CDK4/6 inhibitor plus fulvestrant was significantly longer than with fulvestrant alone in this group of patients (OS at 42 months 57.8% v 45.9%; p=0.00455).
Oncologist Dr Belinda Yeo, from Austin Health and the Olivia Newton-John Cancer Research Unit, told the limbic the PBS listing broadens access to combination strategies for the largest subgroup of patients with advanced breast cancer.
She said standard treatment for patients with metastatic ER+ HER- breast cancer was to use an endocrine therapy in the first, second and potentially even the third line.
“That has been the standard of care for a long time. In more recent years we have had the option in the first line setting to add in the CDK4/6 inhibitor, of which there are several.”
Dr Yeo said despite multiple studies providing efficacy data for fulvestrant alone in metastatic breast cancer, it had not been available on the PBS in recent times.
“Now we have an option with regards to the endocrine therapy backbone and we also have a broader access for the option of combination therapy not just in the first line setting but also at a later line.”
“For ladies and men with ER+ breast cancer, early on in the metastatic process we do like to try chemo sparing options, not just to spare patients chemo but also because the odds of these kinds of manoeuvres may even be greater than chemo.”
In its recommendation to the Health Minister late last year, the PBAC said ribociclib plus fulvestrant was noninferior to ribociclib plus a non-steroidal aromatase inhibitor.
It also noted ribociclib plus fulvestrant provides, for some patients, a significant improvement in PFS and a reduction in toxicity over everolimus plus exemestane.
A statement from the Federal Health Minister Greg Hunt said without the PBS subsidy, an estimated 1,600 patients might pay more than $50,000 per course of treatment.
Fulvestrant Sandoz (fulvestrant) is also being made available on the PBS for the first time as monotherapy for those women in need of this targeted treatment on its own.