The CDK4/6 inhibitor ribociclib (Kisqali) can now be used as first line therapy for pre and peri menopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer after the TGA approved expanded indications for the drug.
The new indication covers use of the drug in combination with a luteinizing hormone-releasing hormone (LHRH) agonist and an aromatase inhibitor (AI) in pre, peri or postmenopausal women, and with fulvestrant as first or second-line treatment in postmenopausal women.
The drug was initially approved in Australia last year as an initial endocrine-based therapy with an aromatase inhibitor combination for HR+/HER2 advanced or metastatic breast cancer in postmenopausal women.
The new indication for the combination in younger women makes ribociclib the first CDK4/6 inhibitor indicated for women regardless of their menopausal status.
The latest TGA approval comes after review of data from the MONALEESA-7 and MONALEESA-3 Phase III clinical trials. MONALEESA-7 focused on pre and perimenopausal women and MONALEESA-3 involved postmenopausal women.
Findings showed prolonged progression-free survival (PFS) and improvements within eight weeks after treatment with the ribociclib-based regimens, when compared to use of endocrine therapy alone.
Speaking to the limbic Professor Arlene Chan, medical oncologist at the Breast Cancer Research Centre in Perth, said the drug in combination with endocrine therapy is reported to have almost doubled the median PFS, compared to endocrine therapy alone, in the MONALEESA-7 trial.
In MONALEESA-3, the ribociclib and fulvestrant combination achieved a median PFS of 14.6 months compared to 9.1 months with fulvestrant alone in patients who had received up to one line of prior endocrine therapy for advanced disease.
Professor Chan, who is an investigator on the MONALEESA trials, said the findings from the phase III studies should be ‘practice changing’.
“We now have a non chemotherapy treatment that includes CDK inhibitors and endocrine treatment, which is producing incredibly effective and durable results so from that point of view we have substantially changed the way we manage patients with this type of metastatic cancer.”