Guideline: FDA issues alert on a drug combination to treat triple-negative breast cancer
|At a glance||Clinical trials|
|Why is this alert important?||Guidelines|
|What is Tecentriq||Questions for your doctor|
|What does this mean for me?||Resources and reference|
This FDA alert is about:
A Food and Drug Administration (FDA) alert warning health care providers, researchers and patients that Tecentriq (atezolizumab) should not be combined with Taxol (paclitaxel) to treat patients with advanced triple-negative breast cancer (TNBC).
Abraxane is not Taxol
Abraxane and Taxol are similar chemotherapy agents. Abraxane is a modified form of Taxol. It has a protein bound to it to help it get into cancer cells. While similar, Abraxane and Taxol are different drugs and they may act differently when used to treat cancer.
This alert is for patients and their doctors. It warns against combining two approved treatments for advanced TNBC. While Tecentriq and Taxol are approved to treat some types of advanced TNBC, the drugs are not approved to be used together.
Tecentriq is a type of immunotherapy known as an "immune checkpoint inhibitor." It is approved for treating people whose metastatic triple-negative breast cancer makes a biomarker known as “PD-L1 (programmed death-ligand 1”. PD-L1 is a protein that helps cancer cells avoid detection by the immune system. The FDA has approved the VENTANA PD-L1 (SP142) companion diagnostic test to see if treatment with Tecentriq would be beneficial for individual patients. This test looks for PD-L1 in cancer cells and is used to find tumors that are most likely to respond to Tecentriq.
On March 8, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Tecentriq in combination with the chemotherapy agent Abraxane for advanced TNBC. This approval was the result of the IMpassion 130 trial which showed that this drug combination improved progression-free survival in patients with advanced TNBC. Learn more about the results of the IMpassion 130 trial here and here.
On September 8, 2020, the FDA warned that Abraxane should not be replaced with Taxol to treat patients with advanced TNBC. The results of the IMpassion 131 trial prompted this alert. The trial found no benefit of Tecentriq combined with Taxol compared to Taxol alone in patients with advanced TNBC.
The FDA continually reviews data from drug trials and reports any potential changes in prescribing information. The IMpassion 131 trial results are preliminary. While trial enrollment is closed, researchers continue to gather new data on participants. The FDA will review these results along with data from other trials that are also looking at the use of Tecentriq combined with Taxol and recommend additional changes if appropriate.
The FDA approval of Tecentriq combined with Abraxane has not changed. This drug combination is approved for treatment of some women with advanced TNBC. The FDA is warning patients and health care providers not to combine Tecentriq with Taxol for patients with advanced TNBC because it does not appear to benefit them. Tecentriq combined with Taxol is approved for other cancers. Patients taking Tecentriq combined with Taxol for other approved indications should continue as directed.
Tecentriq is the first immune checkpoint inhibitor drug approved for breast cancer. If you have been diagnosed with locally advanced or metastatic triple-negative breast cancer, you may want to talk to your doctor about PD-L1 tumor testing and whether the Tecentriq plus Abraxane treatment combination is right for you.
Talk to your health care provider if you have any concerns or questions about your breast cancer treatment. If you have any adverse events or side effects related to treatment with Tecentriq in combination with Abraxane, consider completing the FDA’s MedWatch Online Voluntary Reporting form.
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This article is relevant for:
People with metastatic triple-negative breast cancer
This article is also relevant for:
Breast cancer survivors
Men with breast cancer
Triple negative breast cancer
Women under 45
Women over 45
Be part of XRAY:
- Does this FDA alert affect my treatment?
- How can I have my breast cancer tested for PD-L1?
- Are other tumor biomarker tests available to help guide my treatment?
- Is the Tecentriq plus Abraxane combination treatment an option for my breast cancer?
- What side effects may I experience with Tecentriq plus Abraxane combination treatment?
- Are there other immunotherapy agents that may be used to treat my cancer?
- NCT04177108: A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer. This phase III trial is looking at how well the combination of ipatasertib, an AKT inhibitor, Tecentriq (atezolizumab) and Taxol (paclitaxel) works to treat advanced or metastatic TNBC.
- NCT03498716. A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer (IMpassion030). This study is looking at how well adjuvant Tecentriq (atezolizumab) plus Taxol (paclitaxel), followed by Tecentriq plus doxorubicin or epirubicin (investigator's choice), and cyclophosphamide works compared with Taxol alone followed by doxorubicin or epirubicin and cyclophosphamide in patients with advanced TNBC.
- NCT03961698. Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma (MARIO-3). This phase II trial is looking at how well IPI-549, an oral immunotherapy drug plus Tecentriq and Abraxane works as a first-line treatment for patients with TNBC and in combination with Tecentriq and Avastin (bevacizumab) as a first-line treatment for patients with renal cell cancer.
- NCT03281954. Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo. This phase IIII trial study is looking at whether neoadjuvant therapy (before surgery) with Tecentriq (atezolizumab) plus Taxol compares to neoadjuvant treatment with Taxol alone works to treatment patients with TNBC.
- NCT03424005. A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic or Inoperable Locally Advanced Triple-Negative Breast Cancer (Morpheus-TNBC). This early phase trial is looking at how well multiple immunotherapy drug combinations work for patients with metastatic or locally advanced TNBC.