Sanofi SA (ADR) (SNY), Roche Holding Ltd. (ADR) (RHHBY), GlaxoSmithKline plc (ADR) (GSK): Is the Tide About to Turn in the Fight Against Chronic Lymphocytic Leukemia?

For treatment-naive patients, Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY)’s obinutuzumab, also referred to as GA101, may be the answer. Also a recipient of the FDA’s breakthrough therapy designation, GA101, in combination with chlorambucil, was shown to be significantly more effective than MabThera/Rituxan plus chlorambucil in treatment-naive CLL patients in terms of PFS (23 months versus 10.9 months), and in reducing the risk of the disease worsening or death compared to using just chlorambucil alone (an 86% reduction). GA101 was working so well that an independent monitoring committee stopped the phase 3 trial about a year early because the top-line data was that overwhelmingly in favor of GA101’s superiority over Rituxan. The FDA has granted GA101 a priority review with an action date on or before Dec. 20, 2013. Like ibrutinib, I have a strong suspicion it will be approved.

Finally, within the past few days GlaxoSmithKline plc (ADR) (NYSE:GSK) and Genmab received the breakthrough therapy designation for Arzerra to expand its indications to include treatment-naive CLL patients. The assumed expedited review comes on the heels of an impressive 447-patient late-stage study of Arzerra in combination with chlorambucil compared to a placebo arm of chlorambucil as a monotherapy. In the study, median PFS improved by 9.3 months (22.4 months versus 13.1 months), while the safety profile of the two arms was similar. Not to sound like a broken record, but, given the enormity of improvement, I don’t see how Arzerra doesn’t gain this additional indication.

We’re still obviously a long way from curing cancer, but the progress in treating CLL via the breakthrough therapy designation is undeniable. All three therapies have a genuine shot at adding significant quality of life to CLL patients’ lives, and all aforementioned companies developing these breakthrough designated drugs stand to benefit in a big way.

The article Is the Tide About to Turn in the Fight Against Chronic Lymphocytic Leukemia? originally appeared on Fool.com.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool owns shares of, and recommends Johnson & Johnson. 

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