FDA grants approval for POLIVY™

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval for POLIVY™ (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least 2 prior therapies.

POLIVY Access Solutions is your resource for access and reimbursement support after POLIVY is prescribed. We can help your patients and practice by providing:

  • Benefitsinvestigations (BIs)
  • Priorauthorization (PA) resources
  • Informationabout authorized specialty distributors
  • Sample billingand coding information
  • Resources forappeals
  • Referrals to co-pay support
  • Patientassistance options

A list of authorized specialty distributors is available at Genentech-Access.com/POLIVY.

For more information about POLIVY patient access, please contact me directly or call your POLIVY Access Solutions Case Manager at (888) 249-4918.

Indication Statement

 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 (800) FDA-1088 or www.fda.gov.medwatch. You may also report side effects to Genentech at (888) 835-2555.

 Please see the full Prescribing Information for additional Important Safety Information.

 

 

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