Guideline: FDA issues alert on a drug combination to treat triple-negative breast cancer

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Contents

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


ALERT-AT-A-GLANCE

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.


Why is this FDA alert important?

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.


What is Tecentriq?

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.


Results of the IMpassion 130 and 131 clinical trials and FDA approvals and alerts

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


Context:

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.


Conclusions:

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.


What does this mean for me?

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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Posted 09/17/20

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

Metastatic cancer

Triple negative breast cancer

Women under 45

Women over 45

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Questions to Ask
  • 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?
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