Keytruda, Tecentriq Side Effects May Decrease Survival Chances In Some Patients: FDA

Some cancer patients may face decreased chances of survival due to the side effects of Keytruda and Tecentriq, two popular cancer drugs. 

The FDA issued a warning on May 18, advising health care professionals and oncology clinical investigators about the risk that Keytruda and Tecentriq may lower the chances of survival when used as single therapy.

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. The FDA indicates that there is no change so far in the adverse event profile of the two drugs.

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 issued new recommendations for health care professionals calling for them to be aware of the new data, and to carefully follow the label recommendations on selecting patients for Keytruda or Tecentriq treatment.

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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