aBC or mBC: FDA expands approval of ribociclib under new, faster oncology pilot review process

  • FDA

  • curated by Miriam Davis, PhD
  • Oncology drug update
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Takeaway

  • Under a new review process, the FDA broadened approval of ribociclib (Kisqali; sponsor Novartis) combined with an aromatase inhibitor to include pre-/perimenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced (a) or metastatic breast cancer (mBC). Ribociclib+aromatase inhibitor had previously been approved only in postmenopausal women.
  • The FDA also approved ribociclib in combination with fulvestrant for postmenopausal women with HR+/HER2 aBC or mBC as initial endocrine-based therapy or after disease progression on endocrine therapy.

Why this matters

  • Expanded approvals enable more women to take advantage of ribociclib as a treatment option.
  • New review process facilitates FDA evaluation of other oncology drugs.

FDA's 2 New Pilot Review Programs

  • Real-Time Oncology Review enables the FDA to review the sponsor’s data after clinical trial results are available but before the sponsor submits data to the FDA.
  • The Assessment Aid enables the sponsor to voluntarily organize its submission to the FDA, using a structured template.

Ribociclib Clinical Trials

  • 1 clinical trial of 495 pre-/perimenopausal women found that ribociclib+aromatase inhibitor had a longer median PFS of 27.5 vs 13.8 months on placebo+aromatase inhibitor.
  • The second trial of 726 postmenopausal women found that ribociclib+fulvestrant had a longer median PFS of 20.5 vs 12.8 months on placebo+fulvestrant.

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