FDA grants Roche’s Obinutuzumab Priority Review for Previously Untreated Chronic lymphocytic leukemia

July 4 2013 | By Márcio Barra

In May this year, Roche filed their chronic lymphocytic leukaemia drug, obinutuzumab, for market approval in Europe, via the EMA, and in the US via the FDA.  Back then, the FDA granted Obinutuzumab ‘breakthrough therapy designation’. Now, the FDA has granted Obinutuzumab Priority Review Status for the treatment of chronic lymphocytic leukemia (CLL) on top of the breakthrough drug designation, speeding up the final marketing decision from the standard 10 months to 6 months. FDA’s expected decision date is December 20, 2013.

The FDA is currently evaluating data from the pivotal Phase III CLL11 trial. Data from the trial  showed that patients taking Obinutuzumab had a 86%reduction in the risk of disease worsening or death when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with CLL.

Obinutuzumab can be seen as Roche’s response to Rituxan losing its patent in Europe this year. Obinutuzumab, or  GA101, is an antibody created to improve the immune system’s capability to attack and kill B cells, from which chronic lymphocytic leukemia originates. From the clinical trial data released thus far, the drug shows marked improvements over Roche’s own Rituxan, due to its increased potency in attacking B cells.

A December 20, 2013 approval date would be great news for Roche, as it would allow company to add a branded biologic to their portfolio sooner than later, as its branded Rituxan will soon lose its patent protection. Rituxan added close to $6 billion in sales to the firm’s 2012 balance sheet.

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