OncoPharm Adjuvant Abemaciclib
Oct 14, 2021
Dive into the recent FDA approval of abemaciclib, a groundbreaking adjuvant therapy for high-risk HR+, HER2-negative breast cancer. Discover insights from the Monarchy trial, including who qualifies for this treatment and its potential side effects. The conversation also expands to the new indications for pembrolizumab and brexucabtagene autoleucel, showcasing continuous evolution in oncology. Plus, catch a critical correction regarding tumor classifications that adds to the depth of understanding.
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Selective Approval For Abemaciclib
- The FDA approved 2 years of adjuvant abemaciclib for select high-risk HR+, HER2- early breast cancer based on the MonarchE trial subgroup.
- The approval targets patients with specific high-risk features after chemotherapy, not all early HR+ HER2- cases.
Approval Derived From Cohort 1 Subgroup
- The FDA label is derived from cohort 1 of MonarchE and applies to a specific high-risk subgroup, not the whole trial population.
- Do not assume all early-stage HR+ HER2- patients qualify; check the cohort criteria and Ki-67.
Test Ki‑67 Before Prescribing
- Test tumor Ki-67 before considering adjuvant abemaciclib because the approval requires Ki-67 >20% for the cohort in question.
- Confirm node and size/grade criteria to determine eligibility under the label.