Keytruda, Tecentriq Get New Bladder Cancer Restrictions From FDA

Federal regulators are placing new restrictions on Keytruda and Tecentriq, indicating that the cancer drugs cannot be used on some bladder cancer patients. 

On June 20, the FDA announced that it was placing new label information on Keytruda and Tecentriq, warning that the drugs are not to be used on patients with locally advanced or metastatinc urothelial cancer patients who are not eligible for cisplatin-containing therapy. The new restrictions come about a month after the FDA issued a warning that the drugs may lower patient survival rates when used as a single therapy.

The FDA indicates that the new label Tecentriq and Keytruda warnings are a result of those lowered survival rate concerns.

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The risk appeared during clinical trials and affected patients with metastatic urothelial cancer, who have not received previous cancer treatment and who have low expression of programmed death ligan 1 (PD-L1); a type of protein. The risk was noticed by the Data Monitoring Commitees (DMCs) for the KEYNOTE-361 and IMVIGOR-130 clinical trials.

Both Merck, which manufactures Ketruda, and Genentech, which manufactures Tecentriq, stopped enrolling patients with low PD-L1 in their tumors.

According to the new restrictions, Keytruda is restricted to bladder cancer patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy, and whose tumors express PD-L1 of 10 or higher, or in patients who cannot be given any chemotherapy containing platinum. The restrictions do not affect the drug’s use for other types of cancer.

The restrictions for Tecentriq are similar, except for the PD-L1 restriction. Instead, it is restricted to those whose tumors express PD-L1 covering five percent or more of the tumor area.

Keytruda Health Concerns

Keytruda has been linked to an increased risk of death in a number of recent clinical trials.

In August 2017, the FDA issued a safety alert announcing that it had halted two other Keytruda clinical trials, KEYNOTE-183 and KEYNOTE-185 involving the use of Keytruda to treat multiple myeloma, due to a number of patient deaths.

In KEYNOTE-183, the FDA found that the use of Keytruda, in combination with dexamethasone and either of two immunomodulatory agents; lenalidomide or pomalidomide, led to a 61% increased risk of death. The agency found that 29 patients in the Keytruda arm of the clinical trial died, compared to only 21 deaths among the control patients, who did not receive the drug.

KEYNOTE-185’s results were even worse. That clinical trial, involving about 300 patients, saw an even higher risk, with more than twice as many Keytruda patients dying than those in the control group, 19 to 9. That trial also showed that 54% of the patients given a Keytruda-based drug combination had a 54% chance of severe adverse health effects, compared to only 39% in the control group.

“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,” the agency noted. “Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their health care professional.”

The agency also calls for health care professionals and patients who experience adverse events or side effects linked to these drugs to contact the FDA’s MedWatch Adverse Event Reporting Program.


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