GlaxoSmithKline says that the US Food and Drug Administration has given the green light an expanded label for its anti-cancer therapy, Bexxar (tositumomab and I131), to include patients with relapsed or refractory low-grade non-Hodgkin’s lymphoma, including those that have failed on an alternative treatment.
The drug was originally approved in the summer of 2003 to treat patients whose disease is refractory to Genentech's Rituxan (rituximab) and has relapsed following chemotherapy [[01/07/03e]]. The firm will likely be delighted with the new approval, which could give Bexxar a significant boost over Biogen Idec’s competing product, Zevalin (ibritumomab tiuxetan), which has captured the lion’s share of sales.
The latest application was filed with the FDA back in July 2004 [[07/07/04g]], and it was granted priority review status. “We are pleased that the FDA has moved so quickly to make Bexxar available to a larger group of patients,” said Kevin Lokay, vice president of oncology and acute care at GSK.
- Meanwhile, GSK has signed a two-year US co-promotion agreement with Adolor Corporation for its anti-thrombotic agent Arixtra (fondaparinux). Adolor says it will begin recruiting 30 “surgeon-focused sales representatives” who will collaborate with GSK’s sales representatives in a combined national effort to co-promote Arixtra. The collaborative salesforce could also potentially focus on GSK’s Entereg (alvimopan), once it wins FDA clearance, which is expected by the end of April this year [[09/09/04f]].