The drug nivolumab (trade name: Opdivo) has been approved in Germany since July 2015 for the treatment of advanced lung cancer. It is an option for adults with advanced non-small cell cancer who have already had chemotherapy.
Lung cancer is caused by the growth of malignant cells in the airways (bronchi) and their branches (bronchioles). It is also referred to as bronchogenic carcinoma. There are two main types of tumors:
- Small cell lung cancer, SCLC
- Non-small cell lung cancer, NSCLC
Depending on the result of a tissue examination, non-small cell carcinomas are classified into these groups:
- Squamous cell carcinoma
- Large cell carcinoma
Non-small cell carcinoma is surgically removed, if possible. But sometimes the tumor has already become too large or the cancer has spread to other parts of the body (metastasis) through the blood or lymphatic system. This is called advanced lung cancer.
The aim of treatment with this new drug is to stimulate the immune system to fight the cancer.
Nivolumab enters the bloodstream directly through a vein infusion (an IV drip). This infusion takes about 60 minutes and is given every two weeks. The exact dose is determined by body weight.
Treatment is stopped if it is no longer tolerated or the disease gets worse.
The standard therapy option for patients with advanced squamous cell carcinoma who have already had platinum-based chemotherapy is the drug docetaxel. If docetaxel is not tolerated, the aim is to relieve symptoms such as pain, and improve quality of life tailored to the patient's individual needs. This kind of therapy is known as "best supportive care" (BSC).
The drugs docetaxel, pemetrexed, gefitinib, erlotinib and crizotinib are options for patients with advanced adenocarcinoma or large cell lung carcinoma who have already had treatment, depending on health status, pretreatment and characteristics of the tumor. If these treatments are not possible, they can receive supportive care.
In 2016, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether people with advanced non-small cell lung cancer can benefit from treatment with nivolumab.
The manufacturer provided two studies comparing nivolumab and docetaxel. So it was not possible to tell whether nivolumab has any advantages or disadvantages compared with pemetrexed, gefitinib, erlotinib, crizotinib or BSC. The following results only apply to the comparison of nivolumab and docetaxel.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of nivolumab (Opdivo).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Nivolumab (new therapeutic indication) – Benefit assessment according to §35a Social Code Book V. Dossier assessment A15-32. Cologne: IQWiG. November 12, 2015.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Nivolumab – Addendum to commission A15-32. Dossier assessment A15-58. Cologne: IQWiG. January 13, 2016.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Nivolumab (non-squamous NSCLC) – Benefit assessment according to §35a Social Code Book V. Dossier assessment A16-25. Cologne: IQWiG. July 28, 2016.
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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