Melanoma Drug Approved Even With Its Side Effects.

The testing preceding the OK of this drug is 18 months.  No one knows what the longer term effect of the drug is.
Caviat Emptor (buyer Beware).  On the other hand, if someone has melanoma that has spread, any drug that might arrest the disease is a viable option regardless of the ill effects.

FDA OKs Merck drug for cancer

The Associated Press 4:41 p.m. EDT September 4, 2014

(Photo: Matt Rourke, AP)

WHITEHOUSE STATION, N.J. (AP) — Merck 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% 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% of patients.

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

Important information about Keytruda

Keytruda is a medicine that may treat your melanoma by working with your immune system. It can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening. Call or see your doctor right away if you develop any symptoms of the following problems or these symptoms get worse:

• Lung problems (pneumonitis). Symptoms of pneumonitis may include:
  • shortness of breath
  • chest pain
  • new or worse cough
• Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include:
  • diarrhea or more bowel movements than usual
  • stools that are black, tarry, sticky, or have blood or mucus
  • severe stomach-area (abdomen) pain or tenderness
• Liver problems (hepatitis). Signs and symptoms of hepatitis may include:
  • yellowing of your skin or the whites of your eyes
  • dark urine
  • nausea or vomiting
  • feeling less hungry than usual
  • pain on the right side of your stomach area (abdomen)
  • bleeding or bruising more easily than normal
• Hormone gland problems (especially the thyroid, pituitary, and adrenal glands). Signs and symptoms that your hormone glands are not working properly may include:
  • rapid heart beat
  • weight loss
  • increased sweating
  • weight gain
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • muscle aches
  • dizziness or fainting
  • headaches that will not go away or unusual headache
• Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include:
  • change in the amount or color of your urine.
• Problems in other organs. Signs of these problems may include:
  • rash
  • changes in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness

Getting medical treatment right away may help keep these problems from becoming more serious.

Your doctor will check you for these problems during treatment. Your doctor may treat you with corticosteroid medicines and delay or completely stop treatment with Keytruda, if you have severe side effects.