Merck’s Melanoma Drug may Get FDA approval soon

And there is the approval:


healthyliving.msn.com/health-wellness/fda-oks-merck-drug-1st-in-new-cancer-drug-class


FDA OKs Merck drug, 1st in new cancer drug class© AP // © AP

The genetically engineered drug, known chemically as pembrolizumab, is part of a hot, promising new class of antibody-based drugs.
By The Associated Press

WHITEHOUSE STATION, N.J. (AP) -- Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments.

The Food and Drug Administration said it has granted accelerated approval to Merck's Keytruda, for treating melanoma that's spread or can't be surgically removed, in patients previously treated with another cancer drug.

The genetically engineered drug, known chemically as pembrolizumab, is part of a hot, promising new class of antibody-based drugs. They work by taking a brake off the immune system so it can better recognize and attack cancer cells.

"Ninety percent of patients have basically no side effects," Dr. Antoni Ribas, a UCLA researcher who was the lead investigator of a crucial study of Keytruda, told The Associated Press in an interview.

By comparison, most patients getting chemotherapy suffer with nausea, vomiting and hair loss.

In addition, Ribas said, Keytruda and other "immune-therapy" drugs appear likely to work against many more types of cancer than older drugs, and in a much higher percentage of patients. In a study of 600 patients, one-third of them benefited from the drug, with 62 percent of those alive after 18 months.

Chemotherapy drugs have an average survival of about nine months, while some newer cancer drugs on average keep patients alive for 11 to 15 months, he noted.

"This is just the start," Ribas said, adding that earlier tries at immune therapy for cancer typically helped only 5 to 10 percent of patients.

Merck's drug is the first in the class of what's called anti-PD-1 drugs approved in the U.S.

Bristol-Myers Squibb Co. and a partner have a drug similar to Keytruda, called Opdivo, that was approved in Japan in July. They are seeking U.S. approval for it.

For any of you interested in ONCS, the CEO Punit Dhillon just blogged the following:

punitdhillon.com/2014/09/05/one-small-step-for-merck-one-small-step-for-mankind/


One Small Step For Merck, One Small Step For Mankind

September 4, 2014 – a day that will echo through the halls of history…

Yesterday afternoon, the FDA granted accelerated approval to Merck’s anti-PD1 drug Keytruda, formerly known as MK-3475, for advanced or unresectable melanoma no longer responding to current therapies. I applaud the FDA’s swift approval, and believe that this decision marks a great turning point for immuno-oncology.

For centuries, the promise of cancer immunotherapy has been well regarded. However, the development of such treatments has been held back by a lack of understanding and an absence of safe and effective technologies. As our understanding of tumor biology has expanded and evolved, we have come to realize a simple truth: if tumors use specific interactions to subvert the body’s immune system, we can manipulate these interactions to empower the immune system against cancer. Our enhanced understanding has shown us that a “precision” approach, using combined immunotherapies, is treating cancer the way nature intended. Keytruda’s swift approval serves as a major signal that this intention looks to be fully realized far sooner than many would think.

Keytruda is part of a class of drugs known as ‘checkpoint inhibitors,’ which act by inhibiting immune checkpoint interactions. These drugs are designed to block the tumors ability to exploit natural regulatory elements of the immune system – a method that tumors use to “hit the brakes” on an immune response. By counteracting this tactic, checkpoint inhibitors are able to “cut the brakes” on an immune response. Keytruda targets a regulatory element known as programmed cell death protein 1, or PD1. The first approved checkpoint inhibitor for melanoma, Yervoy, targeted a different element, known as CTLA4. While Yervoy has a response rate around 10%, Keytruda, along with similar next-generation of checkpoint therapies, have been reportedly able to generate response rates around 30-40% in the same patient population.

While this is a significant step forward, the situation remains such that a majority of late-stage sufferers will not respond to these potentially life-saving drugs. Even more, melanoma is classified as being one of the most highly immunogenic cancers. This means that as next-gen checkpoint inhibitors are approved and expanded to address a wide variety of tumor types, the responder population will constitute an even smaller proportion for most all other indications. I stand by my statement that the need for a transformative therapy, which is capable of converting checkpoint inhibitor non-responders into responders, will likely constitute the greatest unmet medical need of our generation. I believe that OncoSec’s ImmunoPulse platform has the potential to address this need, and allow the successes of these drugs to ring out to many more patients faced with life-threatening disease. Keytruda’s approval has done much to advance the realm of cancer immunotherapy. Now, it is our turn at OncoSec to build off this progress and act as a key contributor to the future of cancer therapy: a future that employs combination-based immunotherapy approaches to treat cancer the way nature intended.

The statements or opinions expressed on this site are my own and do not necessarily represent those of my employer OncoSec Medical.

This is what I was referring to in the ACTC forum the other day when I was talking about other stocks/companies with just as much if it not more potential than ACTC:

"I stand by my statement that the need for a transformative therapy, which is capable of converting checkpoint inhibitor non-responders into responders, will likely constitute the greatest unmet medical need of our generation."