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Inside the CHMP’s Refusal of Novartis’s Arzerra as a Maintenance Treatment

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CHMP’s negative recommendation  

The European Medicines Agency’s CHMP (Committee for Medicinal Products for Human Use) gave a negative recommendation to Novartis’s (NVS) Arzerra for use as a maintenance treatment for CLL (chronic lymphocytic leukemia) on June 23, 2016.

Novartis may request a re-examination of the drug in order to extend its marketing authorization to include the use of Arzerra as a maintenance treatment for chronic lymphocytic leukemia.

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What is Arzerra?

Arzerra is an oncology drug indicated for the treatment of patients with previously untreated CLL. Arzerra is used in combination with other medicines like Chlorambucil and Bendamustine and contains the compound Ofatumumab, which is a monoclonal antibody that destroys cancerous B lymphocytes by attaching to the protein CD20.

Novartis expected Arzerra to be used as a maintenance treatment for patients who have undergone at least two prior treatments for CLL and are at high risk of relapsing.

Reasons for negative recommendations  

The CHMP gave negative recommendations for the use of Arzerra as a maintenance treatment for CLL due to the following factors:

  • uncertainty about the observed effect on the progression-free survival after use, as the findings were not supported with information on overall survival and the quality of life
  • side effects, including upper respiratory tract infections, neutropenia, and other reactions
  • presently available data does not show significant improvements in the use of Arzerra as a maintenance treatment

Given these factors, the application for extending the use of Arzerra as a maintenance treatment was refused by the CHMP.

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