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FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients

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As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a finding of decreased survival associated with the use of these drugs as monotherapy compared to platinum-based chemotherapy in treatment-naive patients with a low expression of programmed cell death ligand 1 (PD-L1).

The labels of both drugs have been revised to reflect the restricted indications. The relevant excerpts read as follows:

  • Pembrolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10], or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.
  • Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
    • Are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells covering ≥ 5% of the tumor area), or
    • Are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression.

The tests used in the trial to determine PD-L1 expression are listed in section 14 of each label. The FDA is reviewing the findings of ongoing analyses and will communicate new information regarding the PD-L1 assays and indications as it becomes available.

In patients already receiving pembrolizumab or atezolizumab who are responding to treatment and are cisplatin-ineligible, continuation of treatment could be considered, regardless of PD-L1 status. The FDA has not changed the indications of pembrolizumab or atezolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment.

Patients taking pembrolizumab or atezolizumab for other approved uses should continue to take their medication as directed by their health-care professional.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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