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EU Panel Backs Expanding Ribociclib Approval in HR+/HER2- Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, Nov 16, 2018

Liz Barrett

Liz Barrett

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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