Roche's new Gazyva beats predecessor Rituxan at staving off CLL

There are me-too drugs, and then there are me-better drugs. Though pharma companies have launched plenty of the former, they obviously prefer the latter. And with new trial data, Roche ($RHHBY) has more support for its thesis that Rituxan successor Gazyva beats the original.

In a trial to be presented next month at the American Society of Hematology meeting in New Orleans, Gazyva (obinutuzumab) kept chronic lymphocytic leukemia (CLL) at bay for longer than Rituxan did. Combined with the chemo drug chlorambucil, Gazyva helped patients live a median of 26.7 months without their cancer progressing, compared with 15.2 months for the Rituxan-plus-chlorambucil combination.

Plus, three times as many Gazyva patients enjoyed a complete response to the drug, which means that no sign of their cancer remained after treatment; that amounted to 21% of Gazyva patients compared with 7% of Rituxan patients. The margin was even bigger in terms of patients with no detectable disease in the blood after treatment--29.4% of Gazyva patients, compared with 2.5% of those on Rituxan, Roche said.

Approved by the FDA last week to treat CLL, Gazyva was the first "breakthrough" treatment to win the agency's blessing. This new Phase III study adds to the data on the drug, which awaits approval in Europe and other markets. "These new data are important because they showed for the first time that Gazyva significantly extended progression-free survival when directly compared against MabThera/Rituxan," Roche CMO Hal Barron said in a statement. 

Gazyva is one of Roche's new generation of cancer drugs, developed to succeed breakthrough biotech treatments Herceptin, the HER2-positive breast cancer therapy, and Rituxan, also under the MabThera name in Europe and other countries. Last year, the company's new breast cancer treatment Perjeta--an add-on to Herceptin--won FDA approval. The Herceptin-plus armed-antibody drug Kadcyla hit the U.S. market earlier this year. Both treatments have hit the ground running, with 83 million and 108 million Swiss francs worth of first-half 2013 sales, respectively.

The idea is for these newer drugs to win market share as their predecessors near the end of their patent lives. Rituxan's patent expires in the U.S. in 2018, which means Roche has a few years to win doctors and patients over to Gazyva. There's plenty of sales to be had in that market niche; Rituxan brought in more than $7 billion for Roche last year. Besides CLL, Rituxan is used to treat lymphoma and rheumatoid arthritis. As Reuters notes, analysts predict that Gazyva will build up to 1.34 billion Swiss francs by 2018, or about $1.45 billion.

Other drugmakers are angling for the same patients, however. For instance, the FDA recently granted GlaxoSmithKline ($GSK) breakthrough designation for its drug Arzerra, which the company also hopes to get approved for first-line CLL use.

- read the Roche release
- get more from Reuters

Special Reports: Top 15 Drug Launch Superstars - Kadcyla | Top 20 Orphan Drugs by 2018 - Rituxan

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