FDA Places Clinical Hold On 12 Immunotherapy Trials After Deaths In Keytruda Study

After a Keytruda trial in multiple myeloma patients reported increased death rates, the FDA has placed a clinical hold on 12 studies using similar immunotherapy drugs.

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Officials at the US Food & Drug Administration have put 12 clinical trials on hold, Reuters reports, after reviewing troubling data from a study on Keytruda, the immunotherapy drug manufactured by Merck that is currently being tested as a treatment for multiple myeloma.

Blood Cancer Trials Paused After Keytruda Deaths

In July, a series of patient deaths forced the FDA to suspend three Merck-led trials of Keytruda, in which the new medication was being tested in combination with traditional blood cancer drugs (pomalidomide and lenalidomide) made by Celgene, a company based in New Jersey. Now, the controversy over these new immunotherapy products is spilling over to other prominent drugmakers.

Bristol-Myers Squibb & AstraZeneca

On Wednesday, September 6, 2017, representatives at Bristol-Myers Squibb announced that FDA officials had placed a partial hold on three of their own trials, in which the company's cancer drug Opdivo was being tested in patients with multiple myeloma. Under the hold, Bristol-Myers Squibb will not be allowed to enroll new patients in the studies, although patients who were experiencing clinical benefits will continue to receive the medications.

In a press release, Bristol-Myers explained the FDA's decision: "the FDA determined data currently available from non-Opdivo studies indicate the risks of PD-1 / PD-L1 treatment plus pomalidomide or lenalidomide and possibly PD-1 / PD-L1 treatments alone or with other combinations outweigh potential benefit for patients with multiple myeloma."

One day later, AstraZeneca made a similar announcement, saying six of its own Imfinzi trials had been affected. One study was stopped entirely.

"True Cause" Of Safety Risk Is Unknown

Keytruda, Opdivo and Imfinzi all fall under the heading of PD-1 and PD-L1 inhibitors, a new class of chemicals that help the body's immune system recognize cancer cells as "foreign."

Potentially-revolutionary in their benefits, these "immune checkpoint inhibitors" have already gained approvals to treat a wide range of cancers, including melanoma and Hodgkin's lymphoma. The trials put on hold were looking into a new indication, multiple myeloma, a blood cancer that begins in bone marrow.

The first sign of danger came in July 2017, when Merck reported that multiple melanoma patients taking Keytruda had begun to die more often than people taking traditional cancer drugs. That spurred the FDA to take a closer look at similar trials and, while no elevated mortality rates have been reported for Opdivo or Imfinzi, the agency has chosen to play it safe. "The true cause of the safety concerns," according to an FDA press release, has not yet been determined.



The Legal Herald
By | 2017-09-07T14:30:48+00:00 September 8th, 2017|Prescription Drugs|0 Comments

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Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including products liability, nursing home abuse and personal injury.

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