Gilead enters the cancer drug arena as FDA approves Zydelig
- Zydelig (idelalisib) became part of the Gilead pipeline when the company acquired Calistoga Pharmaceuticals in early 2011.
- Zydelig is indicated for treatment of recurrent chronic lymphocytic leukemia in combination with Rituxan (rituximab), as well as two types of non-Hodgkin’s lymphoma -- relapsed follicular B-cell non-Hodgkin’s lymphoma and small lymphocytic lymphoma (as a third-line treatment).
- Approval is based on a pivotal study that was stopped early because it showed a clear benefit.
Zydelig was approved based on the results of a pivotal 220-patient study which showed that patients treated with Zydelig and Rituxan had 10.7 months of disease-free progression, compared with 5.5 months for patients treated with Rituxan and a placebo.
In 2011, Gilead acquired Calistoga for $375 million up front, with the agreement that the deal could be as high as $600 million. Analysts are estimating that peak sales could easily cross the $1 billion mark in spite of the drug’s black box warning for serious side effects and competitive pressure from Johnson & Johnson. Zydelig has the potential to solidify Gilead’s role as a major player in the lucrative oncology drug field.
- www.xconomy.com Gilead Edges Into Cancer Field With FDA OK of Calistoga Drug