Health Canada approve obinutuzumab plus bendamustine for R/R FL patients

On 7th February 2017, Health Canada approved the combination of GAZYVA® (obinutuzumab) and bendamustine followed by GAZYVA® monotherapy for FL patients who relapsed or are refractory to treatment regimens containing rituximab.1

This approval was based on results of the GADOLIN study, a pivotal phase III trial which aimed to compare the efficacy of obinutuzumab plus bendamustine followed by obinutuzumab maintenance (G-B) against bendamustine (B) alone in patients with rituximab-refractory iNHL. The Lymphoma Hub reported updated results of the GADOLIN study, which were presented at ASH 2016. The study included 99 Canadian patients from 10 centers across the country. In the FL patient population, after a median follow-up of 31.2 months, mPFS was significantly higher in G-B arm patients (n = 164) than B arm patients (n = 171); 25.3 vs 14.0 months, respectively (HR, 0.52; 95% CI, 0.39–0.69; P < 0.0001).

The Canadian Cancer Society predict that each year in Canada, approximately 2,800 people are diagnosed with FL.2

Currently, obinutuzumab plus bendamustine followed by obinutuzumab maintenance is approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for rituximab-refractory FL patients. Obinutuzumab is also EMA and FDA approved in combination with chlorambucil to treat patients with treatment naïve CLL.

  1. Health Canada approves GAZYVA® for patients with previously treated Follicular Lymphoma. http://www.newswire.ca/news-releases/health-canada-approves-gazyva-for-patients-with-previously-treated-follicular-lymphoma-613006223.html. [Accessed 2017 Feb 17].
  2. Canadian Cancer Society. Canadian Cancer Statistics 2016 – Special topic: HPV-associated cancers. http://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2016-EN.pdf?la=en. [Accessed 2017 Feb 17].