Posted by : Pradnya Savekar
On : 03 January 2015
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Views : 1497
Roche won FDA approval for a supplemental license application of its chronic lymphocytic leukamia (CLL) drug Gazyva, strengthening its case in competition with rival GlaxoSmithKline(GSK) and adding some ammo to its hemo-oncology arsenal.
The patients who consumed Gazyva (obinutuzumab) in addition to chemotherapy showed improvement in comparison to patients who take Rituxan along with chemotherapy. Thus, the agency decided to add the drug's label on new study data. Patients 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 are prescribed Rituxan and chemotherpy. The number of patients who showed complete responce by Gazyva plus chemotherapy has tripled.
The news predict well for Roche as it tries expanding its market share for Gazyva and fly past competitor GSK, which is hard at work on a rival product. In April'2014, 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 United States, 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. The UK's National Institute for Health and Care Excellence (NICE) said it planned to greenlight Gazyva, for patients who do not respond to other forms of therapy, but only if Roche offers the drug at lower cost.
The blood cancer med chalked up global sales of $7 billion last year ad 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 towards the new drug and transfers sales before generic copycats of Rituxan hit the market as the drug Rituxan soon is going to face patent expiration.