TECENTRIQ (atezolizumab) injection, for intravenous use. Initial U.S. Approval: 2016

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TECENTRIQ (atezolizumab) injection, for intravenous use. Initial U.S. Approval: 2016

INDICATIONS AND USAGE
TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with:
• Locally advanced or metastatic urothelial carcinoma who:
• are not eligible for cisplatin-containing chemotherapy, and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), or
• are not eligible for any platinum-containing chemotherapy regardless of level of tumor PD-L1 expression, or
• have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.
This indication is approved under accelerated approval based on tumor response rate and duration 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 who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDAapproved therapy for these aberrations prior to receiving TECENTRIQ.
DOSAGE FORMS & STRENGTHS
Injection: 1200 mg/20 mL (60 mg/mL) solution in a single-dose vial
Manufactured By: Genentech
Prescribing Information URL: Click Here

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Atezolizumab, sold under the brand name Tecentriq, is a monoclonal antibody medication used to treat urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and hepatocellular carcinoma (HCC). It is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1).

In May 2016, the FDA granted accelerated approval to atezolizumab for locally advanced or metastatic urothelial carcinoma treatment after failure of cisplatin-based chemotherapy. The confirmatory trial (to convert the accelerated approval into a full approval) failed to achieve its primary endpoint of overall survival. In 2018, FDA altered the use of atezolizumab as a first-line treatment for metastatic bladder cancer in people who can't receive cisplatin-based chemotherapy and have high levels of PD-L1.

In October 2016, FDA approved atezolizumab for the treatment of people with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. People with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.

Atezolizumab is also used to treat extensive stage small cell lung cancer.

In March 2019, the FDA approved atezolizumab for the treatment of people with triple-negative breast cancer.

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