CHMP Positive on Roche's Gazyvaro - Analyst Blog


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Roche ( RHHBY ) 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 chemotherapy.

We note that Gazyvaro is approved in the U.S. under the brand name Gazyva.

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 coming months.

The approval of Gazyvaro in the EU will further boost Roche's hematology portfolio which already consists of drugs like MabThera.

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 AbbVie ( ABBV ).

Roche currently carries a Zacks Rank #3 (Hold). Currently, stocks like Allergan ( AGN ) and Gilead Sciences ( GILD ) look attractive in the healthcare sector. Both carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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