In draft guidance, NICE has approved obinutuzumab with bendamustine followed by obinutuzumab maintenance as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen.
The final appraisal document (FAD) follows a review of the evidence collected through the Cancer Drugs Fund (CDF). Although the data is limited at present, it appears to support the clinical trial evidence. In people who had rituximab as first-line treatment, obinutuzumab with bendamustine improved progression-free survival (PFS) and overall survival (OS) compared with bendamustine alone.
Based on the clinical evidence and a commercial arrangement with the manufacturer, the appraisal committee concluded that cost-effectiveness estimates for obinutuzumab with bendamustine are within the range usually considered a cost-effective use of NHS resources.
The dosage for induction treatment with obinutuzumab and bendamustine is:
- Cycle 1: 1000 mg by IV infusion on day 1, day 8, and day 15 of the first 28-day treatment cycle
- Cycles 2-6: 1000 mg by IV infusion on day 1 of each 28-day treatment cycle.
The dosage for maintenance treatment is 1000 mg by IV infusion every 2 months for 2 years or until disease progression.
The decision is open to appeal until Thursday 23 April 2020. The final guidance is expected to be published on 13 May 2020.
