Keytruda is a cancer immunotherapy drug. (pembrolizumab)According to a Merck news release (the drug maker of Keytruda),, was approved by U.S. Food and Drug Administration (FDA), Thursday to help in fighting against renal cell carcinoma. Keytruda is a medicine that is typically used to treat advanced types of cancers such as lung cancer and melanoma, by working with a patient’s immune system.
Thursday’s release stated that the federal health agency granted the go-ahead to use Keytruda as an adjuvant in RCC patients who are considered to be at Intermediate-High or Very High Risk of recurrence after nephrectomy. Keytruda was approved following the pivotal Phase 3 KEYNOTE-564 study results, which showed a 32 percent reduction in the risk for disease recurrence and death compared to placebo.
Dr. Toni K. Choueiri is the principal investigator of this study and the director of Dana-Farber Cancer Institute’s Lank Center for Genitourinary Oncology. She stated that doctors have long tried to use immunotherapy as a method to reduce the chance of kidney cancer recurrence.
“All these efforts have failed. We have a drug now, thankfully. (pembrolizumab)This is an immune checkpoint inhibitor that works in such a patient group. Choueiri, a Harvard Medical School professor, said that the drug is safe and causes a 32 percent reduction in the risk of recurrences or death.”
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Adjuvant therapy is a treatment that augments the primary treatment regimen for a disease. Choueiri stated that adjuvant treatment options for RCC patients are limited and that this patient population is at high risk of recurrence.
Choueiri stated in the release that “pembrolizumab has been approved by the FDA to address a critical unmet medical need.” The phase 3 trial, which involved multiple clinical sites, was a double-blind placebo controlled, randomized, double-blind study that evaluated the use Keytruda adjuvant therapy in 994 patients at high risk or intermediate-high risk of recurrences of RCC or M1 no Evidence of Disease (NED).
The New England Journal of Medicine published a study that randomly assigned 496 patients to receive pembrolizumab, while 498 received a placebo. Pembrolizumab therapy was found to be significantly more effective than placebo in preventing disease. The study showed that 77.3 percent of patients with KEYTRUDA had survived 24 months without any disease, compared to 68.1% in the placebo group.
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Nick Pannone (62-year-old Cape Cod resident) participated in the KEYNOTE-564 trial. He said he was diagnosed with renal carcinoma three years back and was treated for prostate disease six years ago. Pannone claimed he signed up for the double blind study. Although he doesn’t know if Keytruda actually came to him, he said that he was delighted to be part.
Pannone said that dealing with cancer and taking part in the study gave Pannone hope for the future. “It makes me appreciate my family and friends and how they surround me. I’m blessed to have a great family, friends and career,” he shared with Fox news
Dr. Scot Ebbinghaus (Merck Laboratories’ vice President of clinical research) said that Keytruda was the first approved immunotherapy for the adjuvant treatment in certain patients with renal cell cancer. “This milestone is a testament of our commitment to help more people with this disease.”
Source: Fox News