TECENTRIQ is a cancer immunotherapy, which is a medicine designed to work with the body's own immune system. It is a monoclonal antibody designed to bind with programmed death-ligand 1 (PD-L1). PD-L1 is a protein that plays a role in preventing the body's immune system from fighting cancer. By binding to PD-L1, TECENTRIQ may remove the "stop sign" and activate the immune response.1
TECENTRIQ is approved for the treatment of patients with:
Locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy; or, have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.
It is not known if TECENTRIQ is safe and effective in children.
Bladder cancer is the most common type of urothelial carcinoma. Less common forms include cancers of the urethra, ureters and renal pelvis.7
Approximately 222,500 people in the U.S. will be diagnosed with lung cancer in 2017.8
6 in 10
IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression. People in the study were enrolled into one of two cohorts. Cohort 1 consisted of people who had received no prior therapies for locally advanced or mUC and who were not eligible for cisplatin-based chemotherapy. Cohort 2 included people whose disease progressed during or following previous treatment with a platinum-based chemotherapy regimen. Outcomes were evaluated in all patients and in subgroups based on PD-L1 expression.
Most common side effects (≥ 20%) in previously-untreated cisplatin-ineligible people with locally advanced or mUC were fatigue, decreased appetite, diarrhea and nausea. Five people (4.2%) who were treated with TECENTRIQ experienced either sepsis, cardiac arrest, myocardial infarction, respiratory failure or respiratory distress, which led to death. One additional patient (0.8%) experienced inflammation of the brain due to the herpes simplex virus (herpetic meningoencephalitis) and disease progression at the time of death. TECENTRIQ was discontinued for adverse reactions in 4.2% (5) of the 119 people.
Most common side effects (≥ 20%) in previously platinum-treated people with locally advanced or mUC were fatigue, decreased appetite, nausea, urinary tract infection, pyrexia (fever) and constipation. Three people (1.0%) who were treated with TECENTRIQ experienced either sepsis, pneumonitis (lung problems) or intestinal obstruction, which led to death. TECENTRIQ was discontinued for adverse reactions in 3.2% (10) of the 310 people.
The approval of TECENTRIQ for NSCLC was based on results from the global, multicenter, open-label, randomized Phase III OAK and Phase II POPLAR studies that evaluated TECENTRIQ compared with docetaxel in people with metastatic NSCLC whose disease had progressed after platinum-containing chemotherapy. Patients were randomized 1:1 to receive either docetaxel (75 mg/m2 intravenous infusion) or TECENTRIQ (1200 mg intravenous infusion) every three weeks. OAK enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.
Most common side effects (20%) in people with metastatic NSCLC in the Phase II POPLAR study were fatigue, decreased appetite, dyspnea (shortness of breath), cough, nausea, musculoskeletal pain, and constipation. Nine people (6.3%) who were treated with TECENTRIQ experienced either pulmonary embolism (2), pneumonia (lung infection, 2), pneumothorax, ulcer hemorrhage (bleeding ulcer), cachexia secondary to dysphagia, myocardial infarction (heart attack), or large intestinal perforation, which led to death. TECENTRIQ was discontinued for adverse reactions in 4% (6) of the 142 people.
TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if a patient has severe side effects.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
Before receiving TECENTRIQ, patients should tell their healthcare provider about all of their medical conditions, including if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TECENTRIQ in people with urothelial carcinoma include:
The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
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