Swiss firm Roche has received the US Food and Drug Administration (FDA) approval for a new treatment with its new drug, Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for patients with chronic lymphocytic leukemia (CLL) who have not previously been treated.
Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B-cells, and it works by helping certain immune system cells to attack cancer cells.
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It is claimed to be the first drug approved with the FDA’s breakthrough therapy status based on positive progression-free survival (PFS) results from the Phase III CLL11 trial.
Roche chief medical officer Hal Barron said: "Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as based on clinical data, it more than doubled the time people lived without their disease worsening compared to chlorambucil alone.
"We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers."
The CLL11 trial showed that people who were treated with Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death and lived longer without their disease getting worse compared to those who received chlorambucil alone ( 23.0 vs 11.1 months ).
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By GlobalDataThe most common Grade 3/4 adverse events for the patients who received the combination drug compared to chlorambucil alone were infusion-related reactions during the first infusion, low platelet count and low count of certain types of white blood cells.
Roche said that the combination drug did not result in an increased rate of infections in the Gazyva arm.
The company has also filed marketing applications of the drug to other regulatory authorities, including the European Medicines Agency (EMA).
Roche’s independent research unit Roche Glycart has discovered the Gazyva and in the US the drug is part of a collaboration between Genentech and Biogen Idec.
According to the company, the final data secured from the CLL11 trial assessing the direct comparison between Gazyva in combination with chlorambucil and MabThera/Rituxan (rituximab) in combination with chlorambucil (Stage 2), will be released in December 2013.
In addition to Gazyva, the company’s pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).
Image: High-power magnification of a Wright’s stained peripheral blood smear showing chronic lymphocytic leukemia (CLL). Photo: courtesy of Bibi Saint-Pol.
