Gazyva (guh-ZY-vuh) rode through the FDA today with an early approval as Genentech's heir apparent to rituxan for the treatment of CLL in combination with chemotherapy. This was Genentech's (Roche) fifth new cancer drug approval in the past 3 years as the company remains on a roll. The new drug extended median survival time (to 23 months) and also had a low risk of worsening the disease (or death) in any treated patients -- which is known as the hazard ratio of the drug.
The drug did have its unpleasant side effects but not enough to slow down its "breakthrough" status at FDA and its approval landed several weeks ahead of schedule. An FDA spokesman hailed the drug as an important new tool in the fight against CLL and lauded the Breakthrough Therapy Designation Program for making it possible. The new drug will cost approximately $41,300 per course of treatment per patient. See Xconomy for more.
Posted by Bruce Lehr Nov 4th 2013.