Keytruda – FDA approved first Cancer Drug based on Tumor Biomarker

Keytruda a metastatic tumor drug`

FDA has recently granted accelerated approval for a cancer drug by name Keytruda (pembrolizumab). This is the first of cancer drug which has been granted approval based on a tumor’s biomarker without regard to the tumor’s original location. Until now, the FDA has approved all the cancer treatments based origin of cancer, for example, lung or breast cancers.

What is Keytruda?

KEYTRUDA is a prescription medicine used to treat a kind of bladder and urinary tract cancer called urothelial carcinoma.

KEYTRUDA is a prescription medicine used to treat:

  • Skin cancer called melanoma.
  • Lung cancer called non–small cell lung cancer (NSCLC).
  • Head and neck squamous cell cancer (HNSCC).
  • Cancer called classical Hodgkin lymphoma (cHL).
  • Bladder or urinary tract cancer.
  • A microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor.
  • KEYTRUDA may be used in adults and children to treat:
    • Cancer that has spread or cannot be removed by surgery (advanced cancer), and
    • Cancer progressed following treatment, and has no satisfactory treatment options, or can be used to treat colon or rectal cancer.

How do Keytruda works?

Keytruda (pembrolizumab) is mainly used for the treatment of adult and pediatric patients with metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This biomarker is known to be found in the body of patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.

In the clinical trial experiment, it has been found that Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells. The FDA previously approved Keytruda for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. Tumors with these biomarkers are most commonly found in colorectal, endometrial and gastrointestinal cancers, but also less commonly appear in cancers arising in the breast, prostate, bladder, thyroid gland and other places. Approximately 5 percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.

As per the accelerated approval program, it is mandatory for the manufacturer to further study the drug in a clinical trial known as phase 4 confirmatory trials with MSI-H or dMMR tumors patients to verify and describe anticipated clinical benefits of Keytruda.

Accelerated approval program is one of the 4 priority approval designation available during the FDA drug review which allows the institution to fast approve the drug that fills an unmet medical need for serious condition based on a surrogate endpoint.

Read my previous post about the Accelerated approval program from FDA and importance of Surrogate Biomarker.

Side effects of Keytruda:

As per the manufacturer provided details, KEYTRUDA is a medicine that may treat your melanoma by working with your immune system. KEYTRUDA 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 and can lead to death.

The manufacturer has mentioned that during the clinical trials with KEYTRUDA, some patients stopped treatment due to side effects. Treatment with KEYTRUDA, side effects can occur and should be treated as early as possible.

Some of the possible side effects of taking the drug include:

Lung problems (Pneumonitis):

Symptoms of Pneumonitis may include shortness of breath, chest pain, or new or worse cough.

Intestinal problems (colitis):

Includes the problem 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; or 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, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, feeling less hungry than usual, or bleeding or bruising more easily than normal.

Hormone gland problems (thyroid, pituitary, adrenal glands, and pancreas):

Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems, including nephritis and kidney failure:

Signs of kidney problems may include a 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, or low red blood cells (anemia).

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