With new trial data, Roche has more support for its thesis that Rituxan successor Gazyva beats the original. 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.
A number of drugmakers have been looking to get drugs across the finish line for approval of first-line use in the treatment of chronic lymphocytic leukemia, and Roche's Genentech and Biogen Idec have gotten there first. The FDA today approved their drug Gazyva, a successor to Roche's Rituxan that it hopes will offset some of massive sales that drug generates when it finally succumbs to biosimilar competition.
The Cranbury, NJ-based biotech says they will focus on knockoffs of Humira, Rituxan, Avastin, Herceptin and Erbitux.
Roche's heir to the mega-blockbuster cancer drug Rituxan has been put on the inside regulatory track at the FDA, earning priority review status on top of a breakthrough drug designation that is intended to speed a final marketing decision at the FDA.
With the big American Society of Clinical Oncology meeting coming up in two weeks, anticipation about the coming onslaught of data is mounting. Last night, ASCO released some key abstracts for studies to be presented at the meeting, offering an aperitif to oncology-drug followers. Here is a sampling of news, some from our sister publication FierceBiotech.
Roche got a big boost for its bid to position the leukemia drug GA101 (obinutuzumab) as a next-gen successor to its blockbuster Rituxan, posting late-stage data last night that showed that a combination with chemotherapy performed much better than chemo alone or in combination with Rituxan.
Before the massive ASCO meeting kicks off on May 31, the Swiss drug giant plans to unveil data from a late-stage study of its next-gen antibody GA101, which is heir to the throne occupied by the company and partner Biogen Idec's Rituxan.
Celltrion prematurely ended a Phase III trial for a biosimilar version of Roche's ($RHHBY) big seller Rituxan, but the South Korea-based biotech has plans to revive late-stage development of its copycat candidate in the second half of 2013, BioPharm Insight reported.
Roche faces one less potential copycat competitor to its blockbuster Rituxan franchise. The South Korea-based biotech Celltrion has nixed late-stage development of a biosimilar version of Rituxan, which is expected to face knockoff rivals first in Europe and then in the U.S. in the coming years.
Did Roche do the right thing when it took a pass on biosimilars?