Amgen, Inc. (NASDAQ:AMGN)’s Blincyto (blinatumomab), the company’s leukemia drug nearly recorded double the overall survival rate in acute patients suffering from B-Cell precursor acute lymphoblastic leukemia as compared to chemotherapy which is leukemia’s standard cure. Amgen, Inc is one of the top biotech stocks listed at SEC.
This revelation was made after announcing the Phase 3 study results and which the New England Journal of Medicine published. The study for the late-stage cancer compared chemotherapy and Blincyto among high-risk grown up patients suffering from refractory B-cell precursor acute lymphoblastic leukemia (ALL) or Philadelphia chromosome-negative (Ph-) relapsed. The acute lymphoblastic leukemia is one of the most dangerous B-cell cancers
According to the data released, Blincyto recorded an overall rate of survival of 7.7 months above the 4 months from chemotherapy. The Overall Survival is the period of time from either the day the disease is diagnosed or a patient starts treatment for a disease like cancer that people suffering from the same disease are still alive.
The study was done as a confirmatory examination for a mid-stage trial that was used to support the application for accelerated approval designation of Blincyto by the Food And Drug Administration (FDA) in 2014. A confirmatory study is always done to offer more and solid proof about a drug’s safety and efficacy as well as the re-stating the trial’s theory and protocol.
Head of hematology at Germany’s University Hospital of Wuerzburg Dr. Max S. Topp said the Blincyto will offer an alternative to chemotherapy that is both effective and highly innovative.
Blincyto also showed high rates of remission as opposed to chemotherapy. The drug also performed very well on tolerability and safety measures. The drug has been offered the breakthrough therapy status as well as the priority review designation by the Food And Drug Administration. Blincyto is also an approved treatment for refractory B-cell precursor or Ph- relapsed in the United States. The drug also secured conditional commercialization and marketing authorization in the EU.
Amgen executive vice president of research and development Dr. Sean E. Harper said the drug has shown the ability to extend remission rates, improve overall survival and cut on minimal residual disease.