Novartis’ Kisqali has been approved for breast cancer in the US less than one month after being filed with the US Food and Drug Administration.
The drug has been cleared as the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment for pre-, peri- or postmenopausal women with HR+/HER2- advanced breast cancer.
Kisqali (ribociclib) is also the only CDK4/6 inhibitor indicated with fulvestrant as both initial or second-line treatment for postmenopausal women with HR+/HER2- advanced breast cancer.
The approval is based on data from the pivotal MONALEESA-7 and MONALEESA-3 Phase III clinical trials, which showed prolonged progression-free survival (PFS) and improvements as early as eight weeks for Kisqali-based regimens compared to endocrine therapy alone.
In MONALEESA-7, Kisqali plus an aromatase inhibitor and goserelin nearly doubled the median PFS compared to an aromatase inhibitor and goserelin alone (27.5 months compared to 13.8 months) in pre- or peri-menopausal women, while in MONALEESA-3 Kisqali plus fulvestrant showed a median PFS of 20.5 months compared to 12.8 months for fulvestrant alone.
“Compelling data for Kisqali have led to the broadest first-line indications of any CDK4/6 inhibitor,” said Liz Barrett, chief executive of Novartis Oncology. “With this new approval Kisqali has the potential to help even more people in the US live a longer life without progression of disease from this incurable form of breast cancer.”
Kisqali is the first to be approved using the Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to make the development and review of cancer drugs more efficient, while improving FDA’s standard for evaluating efficacy and safety.
With this real-time review, the FDA was able to start evaluating the clinical data as soon as the trial results become available, enabling it to be ready to approve the new indication upon filing of a formal application with the Agency.
The Assessment Aid is a template used by the applicant to organise its submission into a structured format to facilitate the review, which allows the regulators to layer its assessment into the same file submitted by the sponsor.
The programmes were designed to cut back on some of the administrative issues that can expand the time and cost of the review process, including the staffing burdens on the FDA.