Today is an important day for cancer patients. Advanced Melanoma patients are now able to take a powerful new immunotherapy drug from Merck called Keytruda, also known as pembrolizumab.Keytruda is the sixth new melanoma drug approved by the FDA since 2011. The drug is priced at around $12,500 per month and is used for patients with advanced melanoma who are no longer responding to other therapies.

The National Cancer Institute lists Melanoma as the deadliest form of skin cancer, with around 10,000 Americans succumbing to the disease every year.

keytruda-merck-melanomaThis news is a “home run” for  immuno-cology and cancer patients alike. According to Reuters, this is the “first U.S. approval for a promising new class designed to help the body’s own immune system fend off cancer by blocking a protein known as Programmed Death receptor (PD-1), or a related target known as PD-L1, used by tumors to evade disease-fighting cells.”

Here is what Dr. Louis Weiner, director of the Lombardi Comprehensive Cancer Center at Georgetown University had to say about Keytruda:

“This is not a drug that attacks the cancer directly. It enables the immune system to do the job that it is capable of doing. This is the first beachhead that’s been taken. It’s going to be all out assault on many different types of cancer.”

Here is what Dr Rick Pazdur, director of the Office of Hematology and Oncology in the FDA’s drug evaluation center had to say:

“This is a patient population with few options … We are highly encouraged by the response rate and the duration of response. The true benefit of these drugs may be in patients who do not have metastatic disease, but are at risk of recurrence.”

Now that Keytruda has been approved, Merck will begin testing to see if it can also be used to treat earlier stages of Melanoma. This is a very important drug class with implications for other cancers, including hopefully GIST one day. Below are some links for information about immunotherapy clinical trials for GIST.

Trials of immunotherapies in GIST:

 Trials of vaccine therapy in GIST:

In addition, there are currently over 20 phase 1 trials in solid tumors or sarcoma of immunotherapy based drugs that are recruiting. One Keytruda trial looks like it might admit GIST if patients have the indicated biomarker.(unverified)

Stay tuned for more more news about Keytruda as it becomes available.