Alectinib (trade name: Alecensa) has been approved in Germany since February 2017 for the treatment of advanced lung cancer. It can be used in adults who have certain mutated cancer cells that can lead to faster tumor growth.
Lung cancer is caused by the growth of malignant cells in the airways (bronchi) and their branches (bronchioles). It is also referred to as a bronchogenic carcinoma. There are two main types of tumors:
- small-cell lung cancer (SCLC) and
- non-small-cell lung cancer (NSCLC).
NSCLC is surgically removed, if possible. But sometimes it is already too large or has spread to other parts of the body (metastasis) through the blood or lymphatic system. It is then called advanced lung cancer.
Some people with non-small-cell lung cancer have an abnormal enzyme in the tumor tissue called anaplastic lymphoma kinase (ALK). The full name of the cancer is then ALK-positive non-small-cell lung cancer. The enzyme ALK can lead to uncontrolled growth of the tumor tissue.
Alectinib is used to try to block the ALK enzyme, thereby inhibiting further tumor growth.
The drug is available in 150 mg capsules. Four capsules are taken both in the morning and the evening together with a meal. The recommended daily dose of 1,200 mg can be reduced if it is not tolerated. Treatment is stopped if the disease gets worse or if very severe side effects arise.
The standard treatment for people with advanced ALK-positive non-small-cell lung cancer who have not had treatment before is the drug crizotinib. Depending on their general health, the treatment options for people who have had treatment with crizotinib, but have not had chemotherapy yet, are platinum-based chemotherapy in combination with another cytostatic drug – or monotherapy with gemcitabine or vinorelbine.
If people have had treatment with crizotinib and platinum-based chemotherapy before, they can have further chemotherapy with the drugs docetaxel or pemetrexed. If this is not an option, best supportive care (BSC) is used. This should be tailored to the patient's individual needs with the aim of relieving symptoms such as pain, and improving quality of life.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of alectinib compared with the treatments described above for people with advanced ALK-positive lung cancer
The manufacturer provided studies for both questions:
- First-line treatment for people with ALK-positive lung cancer
- Subsequent treatment for people with ALK-positive lung cancer
This information summarizes the main results of reviews produced 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 these reviews and the hearings received, the G-BA passed a resolution on the added benefit of alectinib (Alecensa).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alectinib (NSCLC) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-19. July 28, 2017. (IQWiG reports; Volume 526).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alectinib (non-small-cell lung cancer) – Addendum to commission A17-19. Commission A17-44. September 29, 2017. (IQWiG reports; Volume546).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Alectinib (non-small cell lung cancer) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A17-67. March 28, 2018. (IQWiG reports; Volume 612).
IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.
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. We do not offer individual consultations.
Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.