An extended first-line indolent trial on Zevalin, Cell Therapeutics' radioimmunotherapy, found that patients with follicular B-cell non-Hodgkin's lymphoma who responded to first-line treatment exhibited continued improvement in progression-free survival after Zevalin consolidation therapy. The trial also showed that Zevalin consolidation treatment had no adverse effect on second-line therapies, including stem cell transplants among relapse patients.
Cell Therapeutics has filed a supplemental Biologics License Application for the use of Zevalin as consolidation therapy in follicular non-Hodgkin's lymphoma patients. If approved, the drug would be the only radioimmunotherapy in the U.S. cleared for first-line consolidation therapy, the company said. Zevalin is approved for use in patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.
Cell Therapeutics is paying Bayer Schering for clinical trial data on Zevalin, which Cell Therapeutics plans to use to support its supplemental biologics license application to the FDA for approval to market the drug as a treatment for follicular lymphoma.
Administration changes resulting from this November's elections will not stop the health care IT momentum as the government transitions from the HHS-run AHIC 1.0 to its public-private successor AHIC 2.0. HHS Secretary Michael Leavitt says he is confident AHIC 2.0 will be a success, but admits there will likely be a period of uncertainty as the new administration decides how to proceed.
The European Committee for Medicinal Products for Human Use has moved Bayer's Zevalin closer to receiving marketing authorization in Europe by recommending the drug for untreated follicular lymphoma patients, which is a new use. The European Commission still has to approve the recommendation.