Gilead's Zydelig approved in the EU for rare blood cancers
- Zydelig (idelalisib) has been approved for the treatment of chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL) by the European Medicines Agency (EMA).
- The therapy is intended to be used used as first-line treatment in CLL patients with a 17p deletion or TP53 mutation, and a second-line treatment in all patients. For FL, Zydelig can be used as monotherapy in patients who have been treated with two other types of therapy and are not responding to treatment.
- CLL is the most common type of leukemia in the West, and FL is the most common subtype of indolent non-Hodgkin’s lymphoma.
Zydelig is an important treatment option for patients with both CLL and FL. It is a first-in-line medication that works by inhibiting P13K delta, a protein over-expressed in many B-cell malignancies. Zydelig was approved by the FDA in July.
Pricing is not settled yet, but if its U.S. cost is any indication, it will be in the $7,000- to $7,500-a-month range. When the cost of Rituxan (rituximab) is added, the price is closer to $12,000 per month.
- Pharma Times EU OKs Gilead’s rare blood cancers drug