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2 Information about polatuzumab vedotin

Marketing authorisation indication

2.1 Polatuzumab vedotin (Polivy, Roche) in combination with bendamustine and rituximab has a conditional marketing authorisation for 'the treatment of adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant'.

Dosage in the marketing authorisation

2.2 The recommended dose of polatuzumab vedotin is 1.8 mg per kg, given as intravenous infusion every 21 days in combination with bendamustine and rituximab for 6 cycles. When administered with polatuzumab vedotin, the recommended dose of bendamustine is 90 mg per m2 per day on day 1 and day 2 of each cycle and the recommended dose of rituximab is 375 mg per m2 on day 1 of each cycle. It is recommended that polatuzumab vedotin does not exceed the dose of 240 mg per cycle.


2.3 The cost per item from the company's submission is £11,060 per 140‑mg vial (excluding VAT). The company estimates that the average cost of a course of treatment is £50,416.

2.4 The company has a commercial arrangement, which would have applied if the technology had been recommended.