Update: 21 May 2021
EMA’s review of the IMpassion131 study has confirmed that the results do not show that combining Tecentriq with conventional paclitaxel slows down the progression of the cancer or reduces deaths in patients with locally advanced or metastatic triple-negative breast cancer that cannot be surgically removed. Therefore, in line with the current product information, Tecentriq (atezolizumab) should continue to be used only in combination with nab-paclitaxel.
EMA is reminding physicians to use Tecentriq (atezolizumab) only in combination with nab-paclitaxel and not with conventional paclitaxel when treating patients with locally advanced or metastatic triple-negative breast cancer that cannot be surgically removed.
EMA’s advice follows the release of results from a study, IMpassion131, which did not show that combining Tecentriq with conventional paclitaxel in these patients slowed down the progression of the cancer or reduced deaths.
Tecentriq is only authorised for the treatment of triple negative breast cancer in combination with nab-paclitaxel. Nab-paclitaxel is a formulation of paclitaxel that is attached to a protein that affects how the medicine works in the body.
There is no indication yet that physicians in the EU have been using paclitaxel in place of nab-paclitaxel. However, EMA’s human medicines committee (CHMP) would like to use this opportunity to remind healthcare professionals to follow the recommendations in the approved product information.
Tecentriq was approved for the treatment of triple-negative breast cancer in the EU in August 2019. A study reviewed by the CHMP at the time showed that patients whose cancer produced a certain amount of a protein called PD-L1 lived for an average of 25 months when treated with Tecentriq plus nab-paclitaxel, compared with 18 months when given placebo plus nab-paclitaxel. Patients in the Tecentriq group also lived for longer without their disease getting worse (7.5 months versus 5.3 months).
Triple-negative breast cancer is a type of breast cancer that does not produce the usual receptors (targets) which other targeted cancer medicines act on. As such, there are fewer medicines that can treat patients with this type of breast cancer.
The EMA will review data from the IMpassion131 study and decide if any change is needed to the approved use of Tecentriq with nab-paclitaxel.
More about the medicine
Tecentriq is a medicine for treating the following cancers:
urothelial cancer (cancer of the bladder and urinary system)lung cancera type of breast cancer known as triple-negative breast cancer.
Tecentriq is used for cancers that are advanced or have spread to other parts of the body either on its own or in combination with other cancer treatments. For urothelial and breast cancers, cancer cells must have a certain amount of a protein called PD-L1. For breast cancer, it is used with nab-paclitaxel. For more information see, Tecentriq.
Tecentriq contains the active substance atezolizumab.