Restricted Indications for Keytruda and Tecentriq
June 20, 2018 – The U.S. FDA has restricted the use of Merck’s Keytruda® (pembrolizumab) and Genetech’s Tecentriq® (atezolizumab) in patients who have locally advanced or metastatic urothelial cancer and are not eligible for cisplatin-containing therapy.
The decision stems from clinical trials in which decreased survival was associated with the use of Keytruda or Tecentriq as a monotherapy, compared to the use of platinum-based chemotherapy. Labels for both drugs have been updated to reflect the newly restricted indications.
Under the restricted indications, patients on Keytruda or Tecentriq who have locally advanced or metastatic urothelial carcinoma must be ineligible for cisplatin-containing therapy and have tumors that express PD-L1, or ineligible for any platinum-containing therapy, regardless of tumor PD-L1 expression.
The FDA advises that continuation of therapy with Keytruda or Tecentriq should be considered for patients who are responding to treatment and cisplatin-ineligible, regardless of their PD-L1 status. No changes have been made to the indications for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment.
Patients taking Keytruda or Tecentriq under additional indications should continue treatment as directed by their healthcare professional.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.