Kadcyla - trastuzumab emtansine

What is Kadcyla and what is it used for?

Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine. It is used to treat adults with advanced or metastatic breast cancer (cancer that has spread to other parts of the body) who have previously received treatment with trastuzumab and a taxane (a type of cancer medicine). Kadcyla can only be used when the cancer has been shown to "express" excessive amounts of HER2, ie when the cancer cell produces a high amount of a protein on its surface, called HER2 (human epidermal growth factor), which stimulates the growth of the cell itself.

How is Kadcyla used - trastuzumab emtansine?

Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional experienced in the treatment of cancer patients. It is available as a powder to be made up into a solution for infusion (drip) into a vein. The dose to be administered depends on the patient's body weight and the infusion is repeated every three weeks. If the first 90-minute infusion has been well tolerated, subsequent doses can be given in 30-minute infusions. Therapy can be continued for less. that the disease does not worsen or the patient no longer tolerates the treatment.

During the infusion and immediately following the infusion, patients should be monitored for infusion related reactions including redness, chills and fever. In patients who develop allergic reactions or side effects, the doctor may need to reduce the dose or stop treatment with Kadcyla. For more information, see the package leaflet.

How does Kadcyla work - trastuzumab emtansine?

The active substance in Kadcyla, trastuzumab emtansine, consists of two active components combined together:

  • trastuzumab, a monoclonal antibody (a type of protein) designed to recognize and attach to the HER2 protein, which is present in large quantities on the surface of some cancer cells. By attaching to HER2, trastuzumab activates cells of the immune system, which subsequently attack the cancer cells. Trastuzumab also blocks HER2 from stimulating the growth of cancer cells. About a quarter of breast cancers express excessive amounts of HER2;
  • DM1, a toxic substance that kills cells as they try to divide and grow. DM1 is activated when Kadcyla enters the cancer cell. It binds to a protein found in cells ("tubulin") which is important in forming the internal "skeleton" that cells need to replenish when they divide. By adhering to tubulin in cancer cells, DM1 blocks skeletal formation, preventing cancer cells from dividing and growing.

What benefit has Kadcyla - trastuzumab emtansine shown during the studies?

Kadcyla has been shown to significantly slow the worsening of the disease and prolong the survival of patients with advanced and metastatic breast cancer expressing HER2 who have previously received trastuzumab and a taxane. In one main study involving 991 patients, subjects treated with Kadcyla survived for an average of 9.6 months without disease progression compared to 6.4 months for patients treated with two other anticancer medicines, capecitabine and lapatinib. In addition, patients treated with Kadcyla survived 31 months compared to 25 months in patients treated with capecitabine and lapatinib.

What is the risk associated with Kadcyla - trastuzumab emtansine?

The most common side effects with Kadcyla (which may affect more than 25% of patients) are bleeding (including nosebleeds), increased blood levels of transaminases (liver enzymes), fatigue, muscle and bone pain, and headache. The most common serious side effects are pyrexia (fever), thrombocytopenia (reduced number of platelets), vomiting, abdominal pain, nausea, constipation, diarrhea, dyspnoea (difficulty in breathing) and pneumonia (lung inflammation). For the full list of side effects reported with Kadcyla, see the package leaflet.

Why has Kadcyla - trastuzumab emtansine been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP took into account the significant improvement in survival observed. in patients treated with Kadcyla compared to standard therapy Regarding the safety of Kadcyla, overall side effects were considered manageable and the overall safety profile was considered favorable compared to currently available medicines.

What measures are being taken to ensure the safe and effective use of Kadcyla - trastuzumab emtansine?

A risk management plan has been developed to ensure that Kadcyla is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients. Due to a potential risk of confusion between Kadcyla and Herceptin, due to the similarity in the name of the active substances (trastuzumab emtansine and trastuzumab), the company will provide educational material to all healthcare professionals who may be using Kadcyla or Herceptin, to specify that the medicines they must not be used interchangeably and to communicate the measures that must be taken to avoid medication errors.

More information about Kadcyla - trastuzumab emtansine

On 15 November 2013, the European Commission issued a "Marketing Authorization" for Kadcyla, valid throughout the European Union. For the full version of the Kadcyla EPAR, please consult the Agency's website: ema.Europa.eu / Find medicine / Human medicines / European public assessment reports For more information on Kadcyla therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2013.


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