The European Medicines Agency (EMA) has approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR /HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

The CHMP recommendation of combining ribociclib with any aromatase inhibitor means that, if approved, oncologists could prescribe ribociclib with letrozole, anastrozole or exemestane, giving them the discretion to select the therapy they believe is most appropriate for each individual patient.

“This positive CHMP opinion brings us one step closer to improving the lives of women diagnosed with advanced or metastatic breast cancer throughout Europe,” said Bruno Strigini, CEO, Novartis Oncology.

“There is currently no cure for advanced breast cancer, and approximately 30 percent of those affected by early-stage breast cancer will go on to develop advanced disease. We look forward to working with European health authorities to make ribociclib available to those who may benefit from it as quickly as possible.”

The positive CHMP opinion is based on superior efficacy and demonstrated safety of ribociclib plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 trial.

The trial, which globally enrolled 668 postmenopausal women with HR /HER2- advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer, showed that ribociclib plus the aromatase inhibitor letrozole reduced the risk of progression or death by 44% over letrozole alone at interim analysis1.

Most adverse events in the MONALEESA-2 trial were mild to moderate in severity, identified early through routine monitoring, and generally managed through dose interruption and/or reduction1.

A subsequent, pre-planned analysis of overall survival with an additional 11 months of follow-up demonstrated a median PFS of 25.3 months for ribociclib plus letrozole and 16.0 months for letrozole alone (HR=0.568 (95% CI: 0.457-0.704; p<0.0001))2.

More than half of women with measurable disease taking ribociclib plus letrozole saw their tumour size shrink by at least 30% (overall response rate (ORR) in patients with measurable disease = 55% vs 39%, p=0.00025)2,4. Follow-up to measure overall survival is ongoing as data remain immature4.

The European Commission will review the CHMP recommendation and usually delivers its final decision within two months.

The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.

Additional regulatory filings are underway with other health authorities worldwide.

In March 2017,  ribociclib was approved by the US Food and Drug Administration (FDA) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with HR /HER2- advanced or metastatic breast cancer.

Ribociclib can be taken with or without food as a once-daily oral dose of 600 mg (three 200 mg film-coated tablets) for three weeks, followed by one week off treatment.

Ribociclib is taken in combination with four weeks of any aromatase inhibitor.

Globally, an estimated 250,000 women will be diagnosed with advanced breast cancer each year3. Up to one-third of patients with early-stage breast cancer will subsequently develop metastatic disease, for which there is currently no cure5,6.

Source: Novartis