Roche ($RHHBY) won FDA approval for a supplemental license application of its chronic lymphocytic leukemia (CLL) drug Gazyva, strengthening its case over rival GlaxoSmithKline ($GSK) and adding some ammo to its hemo-oncology arsenal.
The agency based its decision to add to the drug's label on new study data that show improvements in patients who take Gazyva (obinutuzumab) in addition to chemotherapy, compared with patients who take Rituxan and chemotherapy. Individuals with previously untreated chronic lymphocytic leukemia who take Gazyva and chemotherapy live nearly a year longer without their disease worsening or dying than patients who take Rituxan and chemotherapy. Gazyva plus chemotherapy also tripled the number of people who showed a complete response, or no evidence of disease--26.1% compared with 8.8% of patients who take Rituxan and chemotherapy.
The news bodes well for Roche as it tries to expand its market share for Gazyva and fly past competitor GlaxoSmithKline, which is hard at work on a rival product. In April, GSK won FDA approval for Arzerra for first-line use on CLL, setting the stage for a showdown with Roche. Roche's Gazyva is also approved for the same indication in the U.S., and both GSK and Roche over the summer won an EU regulatory signoff for their CLL products.
Meanwhile, Roche continues to forge ahead with Gazyva, scoring critical cost-effectiveness recommendations and beefing up R&D. Earlier this month, the U.K.'s drug price watchdog the National Institute for Health and Care Excellence (NICE) said it planned to greenlight Gazyva, or Gazyvaro as it's known outside the U.S., for patients who do not respond to other forms of therapy, but only if Roche offers the drug at a lower cost.
The Swiss drugmaker's progress with Gazyva also comes at a critical moment, as Roche faces a looming patent expiration for Rituxan. The blood cancer med chalked up global sales of $7 billion last year and is the target of a number of biosimilar developers. But Roche hopes that promising data for Gazyva and key regulatory signoffs will be enough to sway physicians toward the new drug and transfer sales before generic copycats of Rituxan hit the market.
- read Roche's statement
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