Published: Thu, May 25, 2017
Medicine | By Daryl Nelson

FDA Breaks New Ground with Expanded Keytruda Indication

FDA Breaks New Ground with Expanded Keytruda Indication

The cancer drug has become the first to be approved by the FDA to treat all cancers with a specific tumour biomarker.

Keytruda belongs to a new class of drugs called PD-1 or PD-L1 inhibitors that help the immune system fight cancer by blocking a mechanism tumors use to evade detection.

The Food and Drug Administration announced this week it granted approval for Keytruda, which is for adult and pediatric patients with "unresectable or metastatic solid tumors" that have these biomarkers.

"An estimated almost one-hundred-thousand people are living with gastric cancer in the U.S., yet little progress has been made in bringing forward new treatment options to these patients for whom chemotherapy has always been the standard of care", said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.

Support for the new indication came from data on 149 patients with MSI-H/dMMR-associated tumors enrolled in five uncontrolled clinical studies of pembrolizumab. The ORR was similar among patients diagnosed with colorectal cancer, 36%, or 1 of the 14 other cancer types, 46%. "For 78 percent of those patients, the response lasted for six months or more", the FDA said.

Merck & Co's immunotherapy Keytruda is on the rise with one approval after the other, and May 23 is it's biggest one yet, Scientific American reported.

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"This is an important first for the cancer community", Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, said in a statement.

The recommended pembrolizumab dose is 200 mg for adults or 2 mg/kg (up to a maximum of 200 mg) for children, administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

MSI-high or MMR-deficient tumors are most commonly found in endometrial cancer, colorectal cancer (up to 5% of metastatic patients), and other gastrointestinal cancers.

Merck now must follow up and conduct studies that confirm the anticipated benefits of the treatment.

It's not ideal, and more research has to be done, but the approval is a landmark because it's the first time a cancer treatment that is not site- or tissue-specific has received the agency's approval.

Both Merck and Eli Lilly could receive tailwinds if the market for cancer treatments responds positively to cancer drug Keytruda, which treats a type of cancer affecting the urinary tract and bladder, and Alimta, which is used in the treatment of nonsquamous non-small cell lung cancer, the Barron's special feature stated. Keytruda can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).

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