INDICATION

TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are PD-L1 selected, as determined by an FDA-approved test, who:

• Have received a prior platinum-containing chemotherapy regimen in the metastatic setting
• Had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen

This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Immune-Related Serious Adverse Reactions

For immune-related adverse reactions, withhold TECENTRIQ treatment if ≥grade 2 adverse reactions occur. Please refer to full Prescribing Information for more information. The following adverse reactions have occurred with TECENTRIQ treatment:

• Immune-related pneumonitis, including fatal cases occurred. Permanently discontinue TECENTRIQ for grade 3 or 4 pneumonitis
• Immune-related hepatitis, including fatal cases occurred. Permanently discontinue TECENTRIQ for grade 3 or 4 events of hepatitis of increased LFTs
• Immune-related colitis, including fatal cases occurred. Permanently discontinue TECENTRIQ for grade 4 diarrhea or colitis
• Immune-related endocrinopathies. Thyroid disorders and adrenal insufficiency occurred with TECENTRIQ treatment. For specific information on dose modifications, refer to Prescribing Information
• Other clinically important immune-related adverse reactions can occur. Meningoencephalitis, myasthenic syndrome, and Guillain-Barré have been observed in patients receiving TECENTRIQ. Permanently discontinue TECENTRIQ for any grade meningitis or encephalitis; or myasthenic syndrome or Guillain-Barré syndrome

Additional Serious Important Safety Information

• TECENTRIQ should be used with caution in patients with a history of autoimmune disease after assessment of the potential risk-benefit balance in an individual patient. These patients were excluded from clinical trials
• TECENTRIQ can cause fetal harm. Advise females of reproductive potential to use highly effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose of TECENTRIQ
• Advise nursing mothers not to breastfeed while taking TECENTRIQ if the benefits of breastfeeding do not outweigh the potential risks to the infant

The most common adverse reactions (rate ≥10%) observed in TECENTRIQ patients were diarrhea, nausea, vomiting, fatigue, pyrexia, decreased appetite, arthralgia, dyspnea, rash, and pruritus.

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.

PDL/122215/0178

Please see full Prescribing Information for additional Important Safety Information.