GlaxoSmithKline ( GSK ) and partner Genmab announced that they have submitted a variation to the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for their oncology drug, Arzerra for an additional indication. The companies are looking to get the drug approved in combination with Leukeran (chlorambucil) in treatment-naive chronic lymphocytic leukaemia (CLL) patients, who have not been previously treated for the disease and are inappropriate for fludarabine-based therapy.
The MAA was submitted on the basis of encouraging top-line data from a phase III study (n = 447) on Arzerra. The study compared the efficacy of Arzerra as an adjunct to another oncology drug at Glaxo, Leukeran (chlorambucil) in treatment-naive CLL patients versus Leukeran alone.
The study met its primary endpoint of progression free survival (PFS/the time a patient lived without worsening of their disease). Data from the study was assessed by an independent review committee. In the Arzerra + Leukeran arm of the study, median PFS of 22.4 months was observed as compared to 13.1 months in the Leukeran arm, representing an improvement of 9.3 months. The full data from the study will be presented at the American Society of Hematology annual meeting, scheduled to be held in Dec 2013.
Meanwhile, Arzerra received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). The FDA granted Breakthrough Therapy designation based on encouraging results from a phase III trial (n > 400) which evaluated the use of Arzerra in treat-naive CLL patients.
We note Arzerra is already approved, since Oct 2009, for the treatment of patients with CLL refractory to Sanofi 's ( SNY ) Campath (alemtuzumab) and Fludara (fludarabine).
Glaxo, a large cap pharma company, carries a Zacks Rank #3 (Hold). We are pleased with Glaxo's pipeline development efforts. A number of pipeline-related news is expected in the coming quarters. Given the declining sales due to generic competition, we believe Glaxo's pipeline must deliver.