MesotheliomaHelp.org Reacts to FDA's Approval of Keytruda Cancer Drug

MesotheliomaHelp.org Reacts to FDA's Approval of Keytruda Cancer Drug

MesotheliomaHelp.org is calling attention today to the U.S. Food and Drug Administration's accelerated approval of Keytruda (pembrolizumab; MK-3475) for the treatment of patients with advanced or surgically untreatable melanoma who are no longer responding to other medications.

MesotheliomaHelp.org has been closely monitoring the drug's approval process after reporting in May that Mavis Nye had become the first mesothelioma patient accepted into a U.K. clinical trial of pembrolizumab. The trial was being run at The Royal Marsden cancer center in the U.K., according to MesotheliomaHelp.org, which provides information for mesothelioma patients and their caregivers.

"Someone has given me hope," Nye told MesotheliomaHelp.org in May, reacting to her acceptance into the Phase I trial, which was being run with no placebo (and thus would allow patients to receive the full benefits of the drug).

Nye is one of the fewer than five percent of mesothelioma patients who have survived five years or longer after being diagnosed with the disease, MesotheliomaHelp.org reports.

On September 4, the FDA announced that it had taken action on Keytruda under its accelerated approval program, or approval that "provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials." The drug is developed by Merck & Co.

The FDA describes Keytruda as a drug that blocks, or inhibits, PD-1, a protein that prevents the body's immune system from attacking melanoma cells. Keytruda is the first programmed death receptor-1 (PD-1) therapy approved in the U.S.

According to the FDA, Keytruda's approval was based on data from an ongoing clinical trial. Twenty-four percent of trial participants who received Keytruda had their tumors shrink for at least 1.4 to 8.5 months. Fourteen percent had progression of disease 2.8 to 8.2 months after initial response, the FDA reports.

The FDA states that it gave Keytruda "breakthrough therapy" designation based on preliminary clinical evidence indicating that the drug "may offer substantial improvement over available therapies."

Additionally, the FDA gave the drug "priority review" (meaning the drug had the potential to be a "significant improvement in safety or effectiveness in the treatment of a serious condition") and designated it as an "orphan drug" (meaning the drug is intended to treat a rare disease).

The FDA states that Keytruda is intended for use with the ipilimumab immunotherapy (and for use with ipilimumab and a BRAF inhibitor for melanoma patients with the BRAF V600 gene mutation).

As the oncology news and information website OncLive reports, numerous clinical trials are currently taking place involving pembrolizumab for treatment of a variety of cancer types, while more than 30 studies are examining the drug.

The FDA has not approved Keytruda for the treatment of mesothelioma.

About MesotheliomaHelp.org

MesotheliomaHelp.org is "America's Mesothelioma Resource." It is one of the web's primary resources for information on malignant mesothelioma and other asbestos-related diseases. The website's team of writers, supporters and sponsors are dedicated to bringing the latest, most comprehensive mesothelioma information to patients, families and caregivers. The site's goal is to provide information that empowers families to participate in making the decisions about their care and to offer some measure of hope and support.