On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Latasha shares her journey with metastatic triple-negative breast cancer and how she and her family face the disease together.
What is the most important information about TECENTRIQ?
TECENTRIQ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.
Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:
Hormone gland problems
Problems can also happen in other organs.
These are not all of the signs and symptoms of immune system problems that can happen with TECENTRIQ. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with TECENTRIQ. Your healthcare provider will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with TECENTRIQ. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with TECENTRIQ if you have severe side effects.
Before you receive TECENTRIQ, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TECENTRIQ when used alone include:
The most common side effects of TECENTRIQ when used in lung cancer with other anti-cancer medicines include:
The most common side effects of TECENTRIQ when used in hepatocellular carcinoma (HCC) with bevacizumab include:
The most common side effects of TECENTRIQ when used in melanoma with cobimetinib and vemurafenib include:
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of TECENTRIQ.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
"The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need. This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.”