Tecentriq - withdrawal of application for variation to marketing authorisation
Application withdrawn
The application for a change to this medicine's authorisation has been withdrawn.
atezolizumab
Post-authorisationHuman
Tecentriq is a cancer medicine already authorised for treating urothelial carcinoma (a cancer of the bladder and urinary system) and a type of lung cancer called non?small cell lung cancer.
It contains the active substance atezolizumab and has been authorised since September 2017. Further information onTecentriq current uses can be found on the Agency’s website.
Tecentriq was also expected to be used in combination with another medicine, bevacizumab, to treat a type of kidney cancer called renal cell carcinoma (RCC) when the cancer is advanced or has spread to other parts of the body.
The intended patients were to have high levels of PD-L1, a protein that the medicine uses to work against cancer cells.
The active substance in Tecentriq, atezolizumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells.
PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD-L1 and reducing its effects, Tecentriq increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.
The company presented data from a main study in 915 patients which compared Tecentriq plus bevacizumab with the cancer medicine sunitinib. The study looked at how long patients lived overall and how long they lived without their disease getting worse.
The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
In its letter notifying the Agency of the withdrawal of application, the company stated that results from the main study were not sufficient to support a new use at present.
The withdrawal letter is available.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Tecentriq.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Tecentriq will continue to be used for treating these cancers. This withdrawal has no consequences on the medicine’s currently authorised uses.