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NOW APPROVED

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this accelerated approval

Indication and Important Safety Information

POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least 2 prior therapies.

Accelerated approval was granted for this indication based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Important Safety Information

Warnings and Precautions

Peripheral Neuropathy: Monitor patients for peripheral neuropathy and modify or discontinue dose accordingly.

Infusion-Related Reactions: Premedicate with an antihistamine and an antipyretic. Monitor patients closely during infusions. Interrupt or discontinue infusion if reactions occur.

Myelosuppression: Monitor complete blood counts. Manage using dose delays or reductions and growth factor support. Monitor for signs of infection.

Serious and Opportunistic Infections: Closely monitor patients for signs of bacterial, fungal, or viral infections.

Progressive Multifocal
Leukoencephalopathy (PML): Monitor patients for new or worsening neurological, cognitive, or behavioral changes suggestive of PML.

Tumor Lysis Syndrome: Closely monitor patients with high tumor burden or rapidly proliferating tumors.

Hepatotoxicity: Monitor liver enzymes and bilirubin.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 3 months after the last dose.

The Most Common Adverse Reactions
The most common adverse reactions (≥20%) included neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, nausea, pyrexia, decreased appetite, abdominal pain, and pneumonia.

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 1-800-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

R/R=relapsed/refractory; DLBCL=diffuse large B-cell lymphoma.

Reference: 1. POLIVY Prescribing Information. San Francisco, CA: Genentech, Inc.; June 2019.