Posted from: Friday, July 06, 2018 - 04:48 PM - Present

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.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.


Last Updated Thursday, September 19, 2019 - 05:55 AM.