Thursday, September 4, 2014

FDA grants accelerated approval to Keytruda for melanoma

CANCER DIGEST – Sept. 4, 2014 – The FDA granted fast-track approval to the first of a new class of drugs that promise to hold the key to turning off cancer cells’ ability to evade the body’s immune system.

The drug, pembrolizumab, was approved for treatment of advanced melanoma that is no longer responding to other drugs. It works by blocking a protein called PD-1, which cancer cells produce to restrict the immune system’s ability to attack melanoma cells. 

Marketed under the brand name Keytruda by Merck, it is intended for use following treatment with ipillmumab, an immunotherapy drug that acts on a gene mutation, BRAF V600, which triggers signals inside cells to rev up growth.

The FDA granted Keytruda breakthrough-therapy-status because Merck has demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. It allows patients access to the drug while the company conducts clinical trials to confirm the early results.

Keytruda showed its potential effectiveness in 173 clinical trial participants with advanced melanoma whose disease progressed after other treatments failed to halt it. All participants treated with either of two doses of Keytruda  responded. In the half of the participants who received Keytruda at the recommended dose of 2 mg/kg, approximately 24 percent had their tumors shrink. This effect lasted at least one to almost nine months and continued beyond nine months in most patients. A similar percentage of patients had their tumors shrink at the 10 mg/kg dose.

The most common side effects of Keytruda were fatigue, cough, nausea, itchy skin (pruritus), rash, decreased appetite, constipation, joint pain (arthralgia) and diarrhea, and has the potential to damage the lungs, colons and hormone-producing glands such as the liver, but this did not occur often. 

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