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Merck’s checkpoint inhibitor Keytruda doesn’t help patients with advanced head and neck cancer live longer, but the failed phase 3 clinical trial, announced Monday night, won’t compel the FDA to rescind the drug’s conditional approval, the company said.

And with that, the pile of evidence pointing towards FDA’s extreme flexibility when it comes to easy drug approvals grows even larger.

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  • In June 2016 a small mole, that I’ve been watching for years on my right arm, started to change. It was getting large, black in color and really looked disgusting. So I made an appointment with my dermatologist. She cut it out sent it out to a lab. A couple days later I was told that It was melanoma. Set up a date a few weeks later for surgery to cut my arm “wide and deep” with the goal of getting all of that melanoma out of my arm. At that same surgery they also removed two of my lymph nodes from under my right arm which were considered to be the “sentinel nodes”. I was told that the “sentinel nodes” are the first place melanoma would show up if it was spreading through my body. So after we got the lab results back regarding the lymph nodes, we were told that there were no signs of cancer. I then went for a pet scan and the pet scan showed no cancer in my body at all. So I was pretty happy.

    Then, six months later, in January of 2017 I went for a follow up pet scan and it showed progression of the disease with probable widespread metastasis throughout the liver, the spleen and throughout the skeleton. From nothing to a very big something in six months. I had a biopsy done on my liver and it showed three inch mass with malignant cells present morphologically favoring melanoma.

    On February 14 2017 I received my first Keytruda treatment. I had 6 treatments, every three weeks from that point on. On August 8, 2017 I had a pet scan and it showed NED.

    It is amazing to think that in February 2017 I was so in so much pain and feeling so sick that I wasn’t sure how long I would even live. And in August 2017 my strength is back, I’m strong, I’m feeling great, I’m living life. And all I can say is thank you Keytruda…you have saved my life.

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