Project name: obinutuzumab/GA101
Disease: Chronic lymphocytic leukemia
Peak sales estimate: $1.5 billion to $2.5 billion
Approved: Nov. 1
Companies: Roche and Biogen Idec
With Gazyva, Roche ($RHHBY) wasn't just trying to follow up on Rituxan, its $7 billion chronic lymphocytic leukemia (CLL) giant; it was trying to top it. And if trial data presented last month at the American Society of Hematology meeting are any indication, Gazyva has done its job. Even so, it's unlikely to earn anything close to what the pioneer has been bringing in.
According to a study comparing the two drugs head-to-head, Gazyva beat out Rituxan at staving off CLL. Combined with chemo drug chlorambucil, Gazyva (obinutuzumab/GA101) helped patients live a median of 26.7 months without cancer progression, compared with 15.2 months for the Rituxan/chlorambucil combo. And not just that: 21% of patients showed no remaining signs of cancer after treatment, while only 7% of Rituxan patients enjoyed the same complete response.
Like predecessor Rituxan, Gazyva targets CD20 to directly attack cancer cells. But the added success could stem from its sugar molecules, which have been engineered to help the drug spur the immune system to act on tumors.
Strong Phase III data was enough to earn Gazyva the FDA's breakthrough therapy designation over the summer, and it became the first fast-track success story when the agency approved it in November. In addition to the promise Gazyva showed in trials, analysts were fond of the drug's provenance. The treatment was discovered by Roche researchers, considered the best experts in the business when it comes to cancer drugs. Biogen Idec ($BIIB) has also upped its R&D game, and it has demonstrated its marketing prowess to boot.
For Roche, Gazyva is one in a new generation of cancer drugs developed to take the place of older blockbuster treatments that may soon fall victim to biosimilar competition. Like breast cancer treatment Herceptin, which now has add-on treatment Perjeta and "Herceptin-plus" drug Kadcyla following in its wake, Rituxan is nearing the end of its patent life. While some, like South Korea's Celltrion, have backed away from developing a copy, biologics makers such as Amgen ($AMGN) could be fielding rivals come Rituxan's 2018 patent expiration date. Roche has between now and then to win over doctors and patients with Gazyva.
But Roche won't be the only drugmaker vying for the same patient population. GlaxoSmithKline ($GSK) has a breakthrough designation for its drug Arzerra, which the British pharma hopes to get approved for first-line use in CLL. The FDA approved the treatment in 2009 as a second-line option, but it generated less than $100 million in 2012 revenue with that limited indication.
Others, too, may not be far down the road. Johnson & Johnson's ($JNJ) new drug Imbruvica also has a breakthrough designation for CLL, and the drug impressed in a 148-patient study. After more than 27 months of treatment, Imbruvica kept cancer progression at bay in nearly all previously untreated patients and almost 75% of those who had failed on other therapies. -- Carly Helfand (email | Twitter)
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