Merck & Co’s Keytruda Received FDA Approval to Treat Advanced Melanoma

Food and Drug Administration (FDA) have given fast-track approval for a drug known as Keytruda (pembrolizumab) – developed by pharmaceutical firm Merck & Co. – to treat sufferers with advanced melanoma who are no longer reacting to alternative therapy.

The acceptance is dependent on the outcomes of clinical studies performed by Dr. Antoni Ribas of the University of California-Los Angeles (UCLA) and co-workers, in which they examined the drug on more than 600 sufferers with advanced melanoma who had not reacted to previous treatments.

In one research, the team treated 173 sufferers with either 2 mg/kg of Keytruda or 10 mg/kg of the drug. The team identified that 24% of sufferers who received the 2 mg/kg dosage of Keytruda experienced tumor shrinking of more than 30%, while a smaller amount of sufferers given the 10 mg/kg dose had tumor shrinkage.

The tumors did not grow back in these sufferers, and the drug’s effects stayed for a minimum of 1.4-8.5 months, with some sufferers seeing effects for even longer.

In another research examining the safety of Keytruda in 411 sufferers with advanced melanoma, the team identified that serious side effects – for instance problems with the lung, colon and liver – were unusual. The most frequent side effects were fatigue, itchy skin, constipation, rash, cough, nausea, diarrhea and joint pain

Keytruda is a very major advance in the therapy of melanoma’

Keytruda is an immunotherapy medicine. It strikes PD-1 – a protein expressed by immune cells that interferes with the efficiency of the immune system. By focusing on this protein, Keytruda stimulates immune cells to harm cancer cells.

Past efforts to treat the cancer by enhancing the immune system had unsuccessful because the PD-1 protein obstructed its activity. But discovering a way to target the protein is what scientists deem a cutting-edge in melanoma treatment.

Dr. Ribas says:

“This drug is a game changer, an extremely important advance in the therapy of melanoma. For sufferers who have not reacted to prior treatments, this drug now offers a very real opportunity to shrink their tumors and the hope of a long-term response to treatment.”

One of the sufferers involved in the clinical studies, over 70-year-old Tom Stutz, was diagnosed with advanced melanoma in June 2011. The cancer had propagated to his lung, liver and other parts of his body. As a outcome, Stutz was on oxygen and not able to walk.

Although he believed he had tiny chance of survival, Keytruda shrank his tumors by 90 percent and stopped regrowth. He is now off oxygen and is capable to walk.

As well as dealing with melanoma, Dr. Ribas states that it is feasible that Keytruda could be used to deal with other cancers identified by the immune system, such as bladder, head, lung, neck and cancers.