Disclosure: The European Medical Journal has engaged in business transactions with Novartis Oncology.
FDA Breakthrough Therapy designation has been given for a combination therapy used as an initial treatment for pre-menopausal women with HR+/HER2- advanced breast cancer. This decision was made following the successful use of ribociclib (Kisqali®, Novartis, Basel, Switzerland) in combination with oral endocrine therapy in the Phase III MONALEESA-7 trial.
Consistent Treatment Benefit
MONALEESA-7 compared the treatments of ribociclib combined with the oral endocrine therapies tamoxifen or an aromatase inhibitor and goserelin, to tamoxifen or an aromatase inhibitor and goserelin in a randomised cohort of 672 pre-menopausal women with HR+/HER2- advanced breast cancer aged between 25 and 58 years. Regardless of whether the combination was with tamoxifen or an aromatase inhibitor, ribociclib showed consistent treatment benefit compared to the overall population.
The median PFS for ribociclib combined with tamoxifen and goserelin was 22.1 months, and combined with aromatase and goserelin it was 27.5 months. This compared to a median PFS of 11.0 and 13.8 months for tamoxifen and goserelin alone and an aromatase inhibitor and goserelin alone, respectively. No new safety signals were observed in this trial and the adverse events were identified early and mostly managed through dose interruptions or reductions, as well as being generally consistent with the MONALEESA-2 trial.
With premenopausal breast cancer being the number one cause of cancer death in women 20–59 years old, it is hoped that the designation will lead to the availability of the treatment in the USA in the near future. “This Breakthrough Therapy designation reflects the significance and promise of the MONALEESA-7 data presented at SABCS last month,” commented Dr Samit Hirawat, Head, Novartis Oncology Global Drug Development. “Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease. We look forward to working with the FDA to make this combination therapy available to premenopausal women living with HR+/HER2- advanced breast cancer in the USA as soon as possible.”
This is the second Breakthrough Therapy designation this treatment has received.
James Coker, Reporter
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