pembrolizumabKeytruda (pembrolizumab) (keytruda, pembrolizumab) is the first FDA approved anti - PD-1 drug that blocks the protein - receptor programmed cell death - PD-1. This type of treatment is called immunotherapy.

Keytruda - medicine, for the first time applied to the treatment of melanoma :

  • which spread and can not be surgically removed (metastatic);
  • after treatment with a drug called ipilimumab, if the therapy has proven ineffective;
  • if the tumor has abnormal gene BRAF, BRAF inhibitors therapy did not bring the expected results.

To date pembrolizumab used to treat and such cancers as lung cancer, breast cancer, cancer of the bladder. Constantly carried out research on the effectiveness of treatment pembrolizumabom and other cancers

It is not known how safe and effective a drug keytruda for children under 18 years.

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Benefits Keytruda treatment in Israel

  1. Israel today - one of the few countries (including the US), which Keytruda is allowed to use the drug.
  2. Keytruda officially used in Israel since 2014 and from 2015 is part of a "basket of essential medicines", in addition to this, the Israeli medical centers involved in the program of clinical trials of the drug - all it allowed doctors to the country to gain experience in its application.

The research results of application Keytrudy (pembrolizumaba) in the treatment of melanoma

In April 2015 it was published the results of a comparative study of the treatment of advanced stage melanoma (with the presence of metastases) and Keytrudoy HEREs (Yervoy). The study involved more than 800 uchstie patsientov.Odna third of patients taking Keytruda biweekly, one-third - three times a week and the remaining one-third of patients are treated according to the standard protocol of treatment Yervoy (ipilimumab).

A year after the start of the study 78% of patients taking Keytruda every two weeks and 68%, taking Keytruda every 3 weeks - were still alive. This compared with 58% of the patient population taking Ervoy ( ipilimumab). OTHER Words with In, treatment Keytruda (pembrolizumab) Reduces the risk of death from 31% to 37% in comparison with Yervoy (ipilimumab) . This significant difference has led to the fact that the study was terminated prematurely and patients lechivshimsya HEREs was allowed to continue therapy with Keytruda. Also, the severity and number of side effects, including inflammatory bowel disease (colitis), were significantly lower among those taking Keytruda.

The results of trials of Keytrudy (pembrolizumaba) in the treatment of lung cancer

According to the studies, in the treatment Keytruda (pembrolizumab) significantly reduced the tumor in 19% of patients with lung cancerat an early stage. Significant reduction of malignancy - at 45% of patients have been diagnosed with an excess of substance called PD-L1, that tumor cells use to interact with PD-1 protein. The results indicate that the expression level of PD-L1 tumors can be used to predict which patients will respond better to cancer drugs that block the PD-1 / PD-L1 interaction.

The mechanism of action pembrolizumab

Keytruda interacts with the immune system, which is the body's natural defense against disease. T cells of the immune system detect and fight infections and diseases throughout the body, including metastatic melanoma.

One of the ways in which the system controls the activity of T-cells is the PD-1 mechanism. Protein PD-1 - a programmed cell death receptor. Some cancerous cells are able to subdue a mechanism maintaining viability. This stops T cells from attacking them. So the cancer continues to grow and spread.

Keytruda immunotherapy is the type that blocks PD-1 protein. The drug helps the immune system to do what it should do - to identify and deal with abnormal cells. However pembrolizumab able to direct the immune system against its own organs and tissues and affect their work. These problems sometimes become very serious and life threatening.


Before you receive treatment with the help of pembrolizumab drug should tell your doctor if there is:

  • problems with the immune system: Crohn's disease, ulcerative colitis, systemic lupus erythematosus;
  • whether organ transplants;
  • malfunction of the lungs or breathing;
  • liver disease or any other medical problems.

It is necessary to consult with a specialist if the patient is pregnant or planning to become pregnant. Keytruda able to cause harm to unborn child. Women who can become pregnant should use effective contraception during treatment and for at least 4 months after the last dose pembrolizumaba. The same applies to breastfeeding. It is unknown how the drug passes into breast milk. You can not breast-feed while taking keytrudu.

It is also important to inform the doctor about all the medicines taken by the patient, including prescription and non-prescription - vitamins, dietary supplements.

Side effects

During treatment keytruda may have undesirable consequences. In a clinical study, 6% of the patients discontinued the drug because of side effects, which should be treated as early as possible. You need to tell your doctor about their appearance.

Potential serious side effects

Problems with the lungs (pneumonia):

  • labored breathing;
  • chest pain;
  • appearance or worsening of his cough.

Disturbances in bowel habits (colitis)

  • diarrhea or increase in the number of stools;
  • Chair black, tarry, contains blood and mucus;
  • pain in the abdomen.

Liver problems (hepatitis):

  • yellowing of the skin and whites of the eyes;
  • vomiting and nausea;
  • pain in the right upper quadrant;
  • dark urine;
  • loss of appetite;
  • bruising.

Irregularities in the hormone system (thyroid, pituitary, adrenal, pancreas)

  • heart palpitations;
  • weight loss or increased;
  • excessive sweating;
  • increased appetite or thirst;
  • frequent urination;
  • loss of hair;
  • feeling cold;
  • constipation;
  • voice changes;
  • muscle pain;
  • dizziness or fainting;
  • persistent or unusual headaches.

Kidney problems, including nephritis and renal insufficiency. Symptoms include changes in the number and the color of urine.

Abnormalities in the work of other bodies:

  • rash;
  • changes in vision;
  • severe or persistent pain in the muscles or joints;
  • severe muscle weakness.

Intravenous keytrudy may cause the reaction:

  • chills and fever;
  • shortness or wheezing;
  • itching or rash;
  • dizziness;
  • feeling faint.

Side effects are treated with corticosteroids (or other) delay, or discontinuation of treatment using keytruda if develop serious complications.

You may also experience widespread common side effects when taking the drug pembrolizumab:

  • feeling tired;
  • cough;
  • nausea;
  • itching;
  • rash;
  • loss of appetite;
  • constipation;
  • joint pain;
  • diarrhea.

How is treatment with keytruda?

The course of treatment for each patient is different. The doctor determines the number of procedures based on experience with the drug interaction of the organism.

Pembrolizumab enters the body intravenously during 30 minutes. It is usually given every three weeks. The doctor prescribes blood tests to identify side effects. If the patient experiences any symptoms, it is important to get medical help immediately. This will prevent them more serious. During treatment, the patient must constantly interact with the doctor. Also, to learn how the patient responds to treatment, the specialist carries out periodic scanning and X-ray.

Pembrolizumab Promising in the treatment of cancer of the bladder

Keytruda (pembrolizumab) shows promising results in the treatment of PD-1 - positive bladder cancer, according to a new analysis, presented by the European Society for Medical Oncology Congress for 2014 years. Researchers tested the drug on 29 participants, patients withbladder cancer .

Patients received 10 mg keytrudy every 2 weeks to complete response, progression or unacceptable toxicity.

The duration of follow-up was 11 months (average 10-13), and 7 patients (21%) continued therapy. In 61% of patients have marked adverse effects associated with drug intake: fatigue, peripheral edema, nausea.

The results showed 24% - overall response using keytrudy as monotherapy and 10% - the complete answer.

  • Overall response - 7 (24.1%)
  • Complete response - 3 (10.3%)
  • Partial response - 4 (13.8%)
  • Stable disease - 4 (13.8%).
  • Cancer Progression - 14 (48.3%).
  • No evaluation - 4 (13.8%)

6 months 58% of patients were alive with a median overall survival was 9.3 months. Reduction of tumor size was achieved in 64% of patients studied.

Pembrolizumab shows an acceptable level of safety and tolerability and provides promising antitumor effect in patients with advanced bladder cancer.

Keytruda in the treatment of breast cancer

Merck & Co company embarked on a major program of clinical trials aimed at drug use Keytruda (pembrolizumab) in the treatment of breast cancer .

The company is experiencing, whether PD-1 inhibitor pembrolizumab can change resistance Roche's Herceptin in patients with breast cancer overexpressing HER2.

Phase tests Ib / II, entitled "Panacea" planned for the first half of 2015 year was carried out with the assistance IBCSG (International Research Group breast cancer) and felt combination keytrudy and Herceptin at her2-positive breast cancer patients where tumor process spread despite treatment with Herceptin.

In the trial 46 patients were registered, the initial results will be known by mid-2017, follow-up studies will end no earlier than 2023.

Merck & Co reported preliminary data on phase Ib patients with triple negative breast cancer. Received a response in 5 of 27 (18.5%) of the patients included in the study, but the reaction time is not reached, despite the duration of therapy is 11 months or more in three of the five members.

  • Overall response - 5 (18.5%)
  • Complete response - 1 (3.7%)
  • Partial response - 4 (14.8%)
  • disease stabilization - 7 (25.9%)
  • Progression of disease - 12 (44.4%)
  • No evaluation - 3 (11.1%)

It carries out studies (Merck Sharp & Dohme Corp) Pembrolizumab as monotherapy for metastatic HER2-negative breast cancer. The beginning of the test was planned for June 2015, the end of November 2019. Participants receive 200 mg of the drug intravenously on the first day of each 3-week cycle for up to 24 months. Participation in research hospitals accept Israel.

Bristol-Myers Squibb (BMS) also tests inhibitor PD-1 Opdivo (nivolumab) in combination with ABRAXANE Celgene in the treatment of HER2-negative metastatic breast cancer.