Polivy™

Drug - Polivy™ (polatuzumab vedotin-piiq) [Genentech Inc.]

January 2020

Therapeutic area - Oncology

Initial approval criteria

Patient must be ≥ 18 years; AND
Patient has a diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified; AND
Patient has had an adequate trial of at least 2 prior therapies; AND
Polatuzumab vedotin-piiq will be used in combination with bendamustine and a rituximab product; AND
Patient does not have a history of transformation of indolent disease to DLBCL; AND
Patient has not had a prior allogeneic stem-cell transplant; AND
Patient has not had an autologous stem-cell transplant within 100 days prior to start of therapy, or is not a candidate; AND
Patient does not have CNS lymphoma; AND
Patient does not currently have grade ≥ 2 peripheral neuropathy; AND
Patient has not had chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of therapy; AND
Patient is not pregnant; AND
Patient will receive prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.

Renewal criteria

NOT eligible for renewal

Quantity limits

1.8 mg/kg/cycle (in 21-day cycles);
Total of 6 cycles (5 months)

Background

Polivy’s accelerated approval was granted for use in combination with bedamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. The accelerated approval was based on complete response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411