The European Medicine’s Agency Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approval of ribociclib (Kisqali) in women with HR+/HER2-negative breast cancer to include use in combination with fulvestrant (Faslodex) as initial endocrine-based therapy, as well as for women who received prior endocrine therapy.1
Ribociclib was also recommended to be approved in combination with endocrine therapy and an LHRH agonist for pre- and perimenopausal patients. The agent is currently indicated in Europe for use in combination with an aromatase inhibitor (AI) as frontline treatment of postmenopausal patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer.
"Today's CHMP opinion brings us one step closer to providing more women with HR-positive/HER2-negative advanced breast cancer in Europe with a treatment option," said Liz Barrett, CEO of Novartis Oncology, the developer of the CDK4/6 inhibitor. "The MONALEESA phase III program enrolled more than 2000 women, giving Kisqali by far the most extensive first-line evidence in clinical trials among any of the CDK4/6 inhibitors. This is another testament to how we are reimagining cancer."
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