FDA Approves Abemaciclib (a CDK4/6 inhibitor) for Early-Stage Breast Cancer
In February 2021, we reported on several studies that looked at the use of CDK4/6 inhibitors in early-stage hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, including the monarchE trial. That trial tested whether the addition of the CDK4/6 inhibitor, abemaciclib (Verzenio), already approved in advanced/metastatic breast cancer, improves outcomes (both invasive disease-free survival [IDFS] and overall survival [OS]) for patients with early-stage breast cancer.
On October 12, 2021, the FDA granted regular approval of abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for early-stage HR+/HER2- breast cancer in individuals at high risk as measured by node-positive disease and a Ki-67 score of 20% or more.
Approval was based on invasive disease-free survival at 36 months. IDFS was 86.1% (95% CI: 82.8—88.8%) for patients receiving abemaciclib plus tamoxifen or an aromatase inhibitor and 79.0% (95% CI: 75.3—82.3) for those receiving only tamoxifen or an aromatase inhibitor. Overall survival data are too early to report.
The toxicities associated with abemaciclib are not trivial. In the MONARCH3 trial that resulted in the approval for metastatic HR+/HER2- breast cancer, approximately 20% of women in the treatment arm had to stop treatment because of side effects, and more than 40% had to have the dose reduced.
As we reported in February, there have been a number of trials looking at the use of these drugs in early HR+/HER2- breast cancer, with mixed results. For instance, two now concluded trials of palbociclib (Ibrance; another CDK4/6 inhibitor) demonstrated no benefit in early breast cancer. The results of another early breast cancer trial, NATALEE (ribociclib [Kisqali]) have not yet been reported.
The question remains. Does the addition of abemaciclib ($13,058.08 per month) with its added toxicities (incidence ≥20%; diarrhea, infections, neutropenia, fatigue, leukopenia, nausea, anemia, and headache), improve overall survival in early breast cancer? Only time will tell. And if it does, will patients tolerate the treatment for two years?
FDA Approval Notice: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-abemaciclib-endocrine-therapy-early-breast-cancer?utm_medium=email&utm_source=govdelivery
Harbeck N, Rastogi P, Martin M, Tolaney SM, et al. Adjuvant Abemaciclib Combined With Endocrine Therapy for High-Risk Early Breast Cancer: Updated Efficacy and Ki-67 Analysis From the monarchE Study. Ann Oncol. 2021 Sep 29:S0923-7534(21)04494-X; https://www.sciencedirect.com/science/article/pii/S092375342104494X#fig2
Verzenio Cost: https://www.lillypricinginfo.com/verzenio
FDA’s Project Confirm
In late October, the U.S. Food and Drug Administration (FDA) announced a new effort called Project Confirm, which aims to promote transparency for its Accelerated Approvals (AA) for oncology indications. More specifically, it provides interested stakeholders with quick access through three web pages to a listing of drugs currently holding an accelerated approval status, those which have been withdrawn, and those which have been advanced to regular approval based on so-called verified clinical benefit.
NBCC believes there is additional information that should be made available in this database to further promote transparency of FDA’s AA decisions. These recommendations were detailed in a letter we sent to the FDA on November 3, 2021 (Click here to view the letter).
Bottom line, we want the FDA to explain the basis for each decision to convert an accelerated approval to full approval, how each surrogate endpoint was validated, and what the unmet need is that warranted AA.
We are pleased to see FDA taking steps to promote transparency of its AA program and believe that the ongoing public conversation must continue. FDA’s AA program at present often operates arbitrarily and contrary to its own guiding rules and our recommendations are intended to take a step toward fixing that problem.
Hearing the truth about breast cancer may surprise you. More importantly, it should motivate you. Our breast cancer myths and truths are backed by science, documented by credible and trusted sources, and chosen because they are issues that are often misunderstood by or misrepresented to the general public.
A few of the common myths we debunk include:
Check out our recently updated myths and truths to equip yourself with additional information to support your advocacy work.
Thank You for Joining Us at Les Girls
NBCC’s 2021 Les Girls Cabaret was held on October 24, 2021 and was a huge success and tremendous fun–all for a good cause. This year, we honored Alec Call and Bryan Johns, cofounders of iS Clincial and longtime NBCC supporters with a Leadership Award, and Sherry Goldman, Nurse Practitioner and longtime NBCC advocate with a Grassroots Advocacy Award.
NBCC wishes to thank everyone who joined us and the performers who gave their time and talent. This evening was made possible through the generous support of our many sponsors, including Title Sponsors iS CLINICAL by INNOVATIVE SKINCARE and Cindy and Alan Horn.
Interested in Becoming a Research Advocate?
A reminder that applications for NBCC’s 2022 Project LEAD® Institute are open!
Apply now for NBCC’s premier science training program for one of two summer sessions: July 24-29, 2022 and July 31 – August 5, 2022.
To learn more about the program and how to apply, please visit our website: Project LEAD Institute.
Bowl With NBCC in NYC to Help Us End Breast Cancer
In New York City on November 9? Join the National Breast Cancer Coalition Fund as we host Women With Balls® NYC!
Invite friends and family to bowl and fundraise to support NBCC.
Register, join a team, start your own, or sponsor a lane today!
2022 NBCC Summit – Save The Date!
Mark your calendar for NBCC’s 2022 Advocate Leadership Summit!
Next year’s annual Summit will take place on April 30 – May 2, 2022 at the Park Hyatt Hotel in Washington, DC, followed on May 3 by NBCC’s Annual Lobby Day. We can’t wait to see you all in person once again! Registration opens soon so keep an eye on our website for updates: Advocate Leadership Summit.
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