Keytruda Side Effects in Multiple Myeloma Combo Treatment Poses Serious Risks: FDA

Combining the cancer drug Keytruda with some other medications to treat multiple myeloma may be deadly for some patients, according to a new warning issued by federal drug regulators. 

The FDA issued a safety alert on August 31, indicating that it has halted two clinical trials, KEYNOTE-183 and KEYNOTE-185, involving the use of Keytruda for multiple myeloma, following a number of patient deaths.

“On July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with this drug, because interim results from both trials demonstrated an increased risk of death for patients receiving Keytruda (pembrolizumab) when it was combined with an immunomodulatory agent as compared to the control group,” the agency warned. “Merck & Co., Inc. was made aware of the issue through an external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017.”

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The trials and risks appeared to be linked to the use of Keytruda in combination with dexamethasone and either of two immunomodulatory agents; lenalidomide or pomalidomide in multiple myeloma clinical trials. Keytruda is currently not approved for use in the treatment of multiple myeloma.

Data from the KEYNOTE-183 trial, which involved about 250 patients, indicates that patients given Keytruda had a 61% increased risk of death, with 29 deaths in the Keytruda arm of the clinical trial, compared to only 21 deaths among the control subjects.

However, data from the KEYNOTE-185 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.

There are a number of other multiple myeloma clinical trials ongoing that either involve Keytruda or similar drugs, known as PD-1/PD-L1 cancer drugs. The FDA is investigating those trials to determine if there is a safety issue with them as well.

The FDA is asking healthcare professionals and patients who experience any adverse events or side effects during Keytruda treatment to report them to the FDA’s MedWatch Adverse Event Reporting Program.

7 Comments

  • GaryMay 14, 2019 at 3:39 pm

    My dad died after 8 treatments. He had a mini stroke prior to the treatment. We were never told stroke was a side effect from keytruda. When his treatments started he had massive headaches and the doctor told him to take Tylenol for 8 weeks. He then had an acute stroke which did so much damage he died. Doctors don’t seem to follow up on the side effects, which killed my dad. Is there a lawsuit aga[Show More]My dad died after 8 treatments. He had a mini stroke prior to the treatment. We were never told stroke was a side effect from keytruda. When his treatments started he had massive headaches and the doctor told him to take Tylenol for 8 weeks. He then had an acute stroke which did so much damage he died. Doctors don’t seem to follow up on the side effects, which killed my dad. Is there a lawsuit against Merck?

  • JUDYDecember 30, 2018 at 11:16 pm

    My husband has had 3 treatments and now he is very short of breath and has a cough. He is now using oxygen where before he just used it occasionally. His lung doc saw him said that his capacity has increase a lot so I think the tumors may have shrank. He had the CAT 2 days ago and I will have him see the oncology guy on Tues. Do not think he should wait til the 7th. He was on 14mg of prednisone bu[Show More]My husband has had 3 treatments and now he is very short of breath and has a cough. He is now using oxygen where before he just used it occasionally. His lung doc saw him said that his capacity has increase a lot so I think the tumors may have shrank. He had the CAT 2 days ago and I will have him see the oncology guy on Tues. Do not think he should wait til the 7th. He was on 14mg of prednisone but we upped it to 20 today on our own in hopes he will breath better. It is the holiday and his doc is out of town.

  • EliotOctober 18, 2018 at 2:26 am

    My mother died after two treatments of Keytruda. About four weeks after receiving her first treatment. Her death was definitely unexpected so quickly. Prior to her second treatment she was walking and driving. Any information or help would be greatly appreciated. Eliot

  • EDwinJuly 24, 2018 at 8:32 pm

    Ava and Cathy, I would like to know your details. My mother only lasted about three weeks after her single Keytruda treatment. thank you

  • JosephApril 5, 2018 at 4:58 pm

    My husband had terrible side effects from Keytruda for his Hodgkins Lymphoma He ended with hardly any feelings in his hands and poor balance with his feet....very very tired to the point he ended up getting 2 strokes plus a speech impedement, and memory loss. Elizabeth

  • CathyNovember 28, 2017 at 3:33 am

    My husband died after 4 keytruda infusions

  • AvaSeptember 27, 2017 at 11:15 am

    My husband died after 2 Keytruda treatments. I can go into detail if contacted.

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