The FDA has approved Keytruda as an adjunct treatment for kidney cancer

Keytruda cancer immunotherapy drug (pembrolizumab), approved by the US Food and Drug Administration (FDA) on Thursday to help fight renal cell carcinoma (RCC), reports news release from Merck, drug maker Keytrud. Keytruda is a drug commonly used to treat advanced types cancers such as lung cancer and melanoma, by working with the patient immune system.

On Thursday, the Federal Health Agency approved the use of Keytruda for adjuvant treatment in patients with RCC who are considered to have a moderate to high risk of recurrence after nephrectomy or nephrectomy and resection of metastatic lesions, the report said. Approval followed the results of key phase 3 trial KEYNOTE-564, in which Keytruda showed a significant reduction in the risk of recurrence of disease or death by 32 percent compared with placebo.

According to the Mayo Clinic, the first sign of the disease is often a kidney stone. (iStock)

Toni K. Choueiri, the study’s primary researcher and director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, told Fox News that doctors have been trying to experiment with immunotherapy for decades as a way to reduce kidney cancer recurrence. .

“All these attempts have failed. Fortunately, we now have a cure (pembrolizumab) which is an inhibitor of immune checkpoints acting in such a patient population. The drug is safe and causes a 32 percent reduction in the risk of recurrence or death, “Choueiri, who is also a professor at Harvard Medical School, told Fox News.

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Adjuvant treatment is described as a therapy used to increase the effects of the primary treatment disease regime. Choueiri said in a statement that adjuvant treatment options are limited for those with RCC and this patient population is often at risk of recurrence.

“With this FDA approval, pembrolizumab can address the critical unmet need for treatment and has the potential to become a new standard of care in an adjuvant environment for appropriately selected patients,” Choueiri wrote in a statement. Phase 3 studies involved multiple clinical sites and was a randomized, double-blind, placebo-controlled trial investigating the use of Keytruda as adjuvant therapy in 994 patients with a moderate to high risk of recurrence of asymptomatic RCC or M1 (NED).

According to a recently published studies in the New England Journal of Medicine, 496 patients were randomized to receive pembrolizumab and 498 received placebo. The study authors found that pembrolizumab treatment was associated with significantly longer disease-free survival than placebo. The study showed 77.3% disease-free survival in the KEYTRUDA group after a 24-month follow-up, compared with 68.1% in the placebo group.

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Nick Pannone, a 62-year-old Cape Cod resident, participated in the KEYNOTE-564 clinical trial and told Fox News that he was diagnosed with kidney cancer three years ago and treated for prostate cancer six years ago. Pannone said he enrolled in a double-blind study and doesn’t know if he actually received Keytrudo, but he told Fox news that I was thrilled to be part of the research.

Surgical instruments are used during a kidney transplant operation at MedStar Georgetown University Hospital in Washington DC, Tuesday, June 28, 2016. (AP Photo / Molly Riley)
(AP)

Pannone said cancer control and participation in the study gave him hope for the future. “Because of this, I value my life and the family and friends around me. I am blessed to have a great family, friends and career,” he told Fox news

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FDA approval means that Keytruda is the first immunotherapy approved for the adjuvant treatment of some patients with renal cell carcinoma, according to Dr. Scott Ebbinghaus, vice president of clinical research at Merck Laboratories, also said in a press release: “This milestone is proof of our commitment to helping more people living with cancer.”