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FDA Approves Ribociclib for Frontline HR+/HER2- Breast Cancer

Jason M. Broderick @jasoncology
Published: Monday, Mar 13, 2017

Gabriel N. Hortobagyi, MD

Gabriel N. Hortobagyi, MD

The FDA has approved the CDK 4/6 inhibitor ribociclib (Kisqali) for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor (HR)–positive, HER2-negative advanced breast cancer.

"Kisqali is emblematic of the innovation that Novartis continues to bring forward for people with HR+/HER2- metastatic breast cancer," Bruno Strigini, CEO, Novartis Oncology, said in a statement. "We at Novartis are proud of the comprehensive clinical program for Kisqali that has led to today`s approval and the new hope this medicine represents for patients and their families."

References

  1. Hortobagyi GN, Stemmer SM, Burris HA, et al. First-line ribociclib + letrozole for postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA1.
  2. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for hr-positive, advanced breast cancer [published online October 8, 2016]. N Engl J Med. doi:10.1056/NEJMoa1609709.

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