The EU Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche’s Gazyvaro (obinutuzumab), combined with bendamustine chemotherapy and then as monotherapy, to treat select patients with follicular lymphoma. The recommendation is as treatment for patients who failed to respond to, or whose diseased advanced despite, treatment with MabThera (rituximab) or a regimen containing MabThera.
“Each time a person with follicular lymphoma experiences a progression of their disease, it becomes harder to treat,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Roche, said in a press release. “Progressive disease is particularly challenging after MabThera-containing therapy, and this CHMP positive opinion for Gazyvaro brings us one step closer to providing a much needed new treatment option for follicular lymphoma patients in Europe.”
CHMP based its opinion on data generated from GADOLIN, an open-label, randomized, and two-arm Phase 3 clinical trial assessing Gazyvaro plus bendamustine, followed by Gazyvaro alone until disease progression or for up to two years, compared to bendamustine monotherapy. (Gazyvaro is marketed as Gazyva outside the EU and Switzerland.)
Results revealed that in those patients who did not respond to, or whose disease advanced during or within six months of, previous MabThera/Rituxan-based therapy, treatment with Gazyvaro in combination with bendamustine — and followed by Gazyvaro alone — caused a reduction of 52 percent in the risk of disease aggravation or death compared to bendamustine monotherapy, as assessed by an independent review committee.
Median progression-free survival (PFS) has not yet been reached in patients treated with the Gazyvaro regimen, and was 13.8 months in patients treated with bendamustine monotherapy. Investigator analyses, however, reported that median PFS in those taking the Gazyvaro regimen was more than double that of the bendamustine monotherapy group (29.2 versus 13.7 months, respectively).
The European Commission is likely to issue a final decision on Gazyvaro shortly.
Gazyvaro/Gazyva, a glycoengineered anti-CD20 monoclonal antibody, is approved in Europe and the United States for patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil.
Approval was based on the Phase 3 CLL11 study, an open-label, randomized three-arm trial that showed that Gazyvaro plus chlorambucil chemotherapy significantly extended the amount of time people lived without their disease worsening, while increasing the length of remissions compared to standard treatments, such as chlorambucil or MabThera plus chlorambucil.
Based on the results of the GADOLIN study, the U.S. Food and Drug Administration approved Gazyva in February 2016, in combination with bendamustine followed by Gazyva alone, for patients with follicular lymphoma who did not respond to a regimen containing Rituxan, or whose follicular lymphoma returned following the therapy.
Follicular lymphoma is a type of non-Hodgkin’s lymphoma that develops when the body makes abnormal B-lymphocytes, or lymphoma cells that build in the lymph nodes. The most common symptom is a painless swelling in the neck, armpit or groin. In Europe each year, about 19,000 people are diagnosed with follicular lymphoma.
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