|ODAC Votes. Win for Industry, Not for Patients.
On April 27, 2021, at the Oncologic Drug Advisory Committee (ODAC) meeting, NBCC advocate and Project LEAD graduate, Michele Atlan, presented NBCC’s position on the current approval status of TECENTRIQ (atezolizumab) in the first line setting of triple-negative breast cancer (TNBC). NBCC strongly opposes the approval of this drug. After numerous clinical trials in thousands of patients, we have no data that demonstrate this drug improves or lengthens lives.
NBCC was disappointed but not surprised with the resulting 7-2 ODAC vote to keep atezolizumab on the market for advanced/metastatic TNBC. That result is consistent with what we have seen now for years—approval of drugs through the accelerated approval process with marginal or, even worse, no clinical benefit to patients.
No data were presented to support continued approval and substantial technical delays and challenges encountered throughout the session left little time for critical questions. These technical issues also left the public unable to even hear the rationale for ODAC members’ votes, and left no time for any discussion, at least that could be heard publicly, about an appropriate confirmatory trial. Recall that the original confirmatory trial failed. NBCC has made its position on this issue clear for some time. Read more here.
We believe that the drug should be withdrawn—so that it can be critically assessed using an appropriate study design and in the right study population, without the inappropriate (and arguably unethical) inclusion of patients whose tumors do not express PD-L1, where mounting evidence has shown no benefit.
So far, we know that the drug has shown no clinical benefit but has risks. And it costs on the order of $13K per month, not including costs of pairing it with nab-paclitaxel. Unsuspecting patients will continue to receive this drug with no proven benefit, potentially for years to come while we wait for results from another “confirmatory” trial.
As Michele Atlan presented, “a key responsibility of the FDA is to protect the public by ensuring the safety and efficacy of drugs that enter the market. And frankly, that’s what patients assume they are getting when a drug is offered to them. In metastatic breast cancer, where there is currently NO CURE, drugs must ultimately confer some clinical benefit over standard of care to retain their approval status.”
In breast cancer, we still have no idea if atezolizumab improves any clinically meaningful endpoint. We do know it can harm. Under the rules guiding accelerated approval, we continue to call on the FDA to remove the provisional approval of atezolizumab in this setting, and to require an appropriate confirmatory trial and evidence of clinical benefit before approving further use of this drug outside of a clinical trial setting. NBCC advocates and patients should accept nothing less.
Patient-Centered Outcomes Research (PCOR) Online Training Now Available!
Beginning in 2019, NBCC conducted a series of webinars supported by PCORI to provide our advocates with comprehensive and structured training in the variety of skills needed for participating in patient-centered outcomes research and informing ongoing breast cancer research. These live webinars, initially conducted exclusively for graduates of the Project LEAD Institute, are now available online for anyone who is interested! Check out the recordings here to start your training.
NBCC Joins as Contributor for Cancer History Project
Created to mark the 50th anniversary of the National Cancer Act of 1971, the Cancer History Project is a free collection of historical documents and articles on the history of cancer. NBCC recently joined other cancer organizations as a contributor to the project, adding NBCC historical documents to the site.
You can visit the NBCC contributor page here and check back often for updates.
Don’t Delay—Time is Running Out. REGISTER Today for the 2021 Virtual Advocate Leadership Summit
Join amazing breast cancer advocate leaders from across the country to network and hear from leading scientists, advocate visionaries, and policy leaders at plenaries, and interactive workshops.
Summit sessions will be hosted at the following times:
This year’s Summit includes a number of exciting plenary sessions as well as numerous workshops. In addition, Project LEAD grads can attend a special workshop on Friday, May 14 on the current status of CDK4/6 inhibitors in early and metastatic breast cancer.
Visit our website to preview the program agenda. We hope to see you online.
More details about the event:
Hear What Advocates Have to Say About the Summit
Honoring All the Women We’ve Lost to Breast Cancer Ahead of Mother’s Day
This Mother’s Day and every day, NBCC honors the mothers we’ve lost to breast cancer by working to end breast cancer once and for all. In honor of the women who are dear to you, in memory of those who are gone, and for the millions of others who are at risk, please donate to NBCC this Mother’s Day and help end breast cancer.