Pembrolizumab (trade name: Keytruda) has been approved in Germany since July 2015 for the treatment of advanced melanoma (skin cancer) in adults. As of December 2018, it is also approved as supportive (adjuvant) therapy after the surgical removal of a melanoma and its lymph node metastases.
Melanoma is the most dangerous type of skin cancer. It starts growing in the cells that produce the dark pigment in skin. Some patients have a mutated protein in the tumor tissue (BRAF V600 mutation), which can cause uncontrolled tumor growth. Melanomas are usually surgically removed. But sometimes they may have already spread to lymph nodes, nearby tissue or other parts of the body (metastasis). The aim of supportive treatment after surgery is to fight any remaining tumor cells in the body and prevent a recurrence.
The aim of treatment with pembrolizumab is to stimulate the immune system to fight the cancer.
Pembrolizumab is given every three weeks at a dose of 200 mg or every six weeks at a dose of 400 mg in the form of an infusion (an IV drip), entering the bloodstream directly through a vein. The infusion takes about 30 minutes. The treatment is stopped if the disease progresses or dangerous side effects arise. Supportive treatment with the drug lasts for about a year.
For the assessment in 2015, pembrolizumab was compared with the following standard treatments for advanced melanoma:
- Dacarbazine or ipilimumab are options if it's the patient’s first treatment and they don't have a BRAF V600 mutation.
- Vemurafenib is an option if it's the patient’s first treatment and they have a BRAF V600 mutation.
- For patients who have had previous treatment, the treatment options depend on things like which drug has been used before. The treatment is individually adjusted by the doctor.
- For the assessment in 2019, treatment with pembrolizumab was compared with watchful waiting. Watchful waiting means that patients are examined regularly in order to detect and treat any recurrence early on.
In 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether pembrolizumab has any advantages or disadvantages for people with advanced melanoma when compared with the standard treatments at the time.
The manufacturer provided data for the following two groups:
- People who have had treatment before
- People without a BRAF V600 mutation who are having treatment for the first time
In 2019, the researchers looked into the advantages or disadvantages of pembrolizumab as supportive treatment when compared with watchful waiting for people who have had surgery to remove a melanoma and its metastases.
This information summarizes the main results of reviews produced in 2015 and 2019 by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of pembrolizumab (Keytruda).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Pembrolizumab – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A15-33. November 12, 2015. (IQWiG Reports; Volume 339).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Pembrolizumab – Addendum to Commission A15-33; Commission A15-56. January 14, 2016. (IQWiG Reports; Volume 357).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Pembrolizumab (melanoma) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-29. June 27, 2019. (IQWiG Reports; Volume 785).
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.
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