) received positive news when the Committee for Medicinal Products
for Human Use (CHMP) recommended the European Commission to approve
Gazyvaro in combination with chlorambucil for the treatment of
adult patients suffering from previously untreated chronic
lymphocytic leukemia (CLL).
These patients had comorbidities and were unsuitable for
We note that Gazyvaro is approved in the U.S. under the brand
The CHMP recommendation for approval was based on positive data
from a phase III study, CLL11. Roche conducted the study in
collaboration with the German CLL Study Group and is evaluating the
efficacy and safety profile of Gazyvaro plus chlorambucil, MabThera
plus chlorambucil and chlorambucil alone in previously untreated
people suffering from CLL.
It was observed from the study results that treatment with
Gazyvaro plus chlorambucil significantly reduced the risk of
disease worsening or death by 86% and increased survival time for
previously untreated CLL patients as compared to those who received
treatment with chlorambucil alone.
In addition, the data from the study showed that Gazyvaro plus
chlorambucil significantly reduced the risk of disease worsening or
death by 61% versus MabThera plus chlorambucil. The study met its
primary end point.
A final decision is expected from the European Commission in the
The approval of Gazyvaro in the EU will further boost Roche's
hematology portfolio which already consists of drugs like
Roche's hematology pipeline consists of candidates such as
anti-CD79b antibody drug conjugate (RG7596/polatuzumab vedotin),
MDM2 (RG7112) and RG7601/GDC-0199/ABT-199, which is being developed
in collaboration with
Roche currently carries a Zacks Rank #3 (Hold). Currently,
) look attractive in the healthcare sector. Both carry a Zacks Rank
#1 (Strong Buy).
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