When it comes to selling big, cancer drugs have a lot going for them. Their targets--deadly diseases that in many cases can kill quickly--put them in high demand, even as they continue to redefine...
Gazyva, Roche's successor to Rituxan, is already approved in the U.S. for first-line use on chronic lymphocytic leukemia (CLL) and appears poised for the same in Europe. The EU Committee for Medicinal Products for Human Use (CHMP) today recommended it for approval there.
Pharma companies sometimes try to extend the lives of drugs by developing new formulations or follow-on products before their patent expires. Swiss pharma giant Roche scored a victory today when European regulators approved a subcutaneous version of its cancer drug Rituxan, known as MabThera overseas.
It is the big sellers, the blockbusters--no, megablockbusters--that drug execs aspire to develop. And a look at the top 10 best-selling drugs globally can't help but impress with its big numbers.
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.