Amgen, Inc. (NASDAQ:AMGN), one of the top biotech stocks, filed a supplemental Biologics License Application to the U.S. FDA to extend the indications of its prime leukemia medication candidate Blincyto. The application comprised updated overall survival data from a Phase III trial to help convert the medicine’s accelerated nod to full approval. Overall Survival is the time period from either the diagnosis date or the start of disease treatment that patients spotted with the illness are still alive.
Amgen filed new data supporting the cure of subjects with Philadelphia chromosome-positive refractory or relapsed B-cell precursor ALL. A relapse shows the deterioration or return of a disease after a duration of improvement, whereas refractory implies a condition which fails to respond to tried forms of treatment.
Amgen has secured a place in the list of top biotech stocks 2017 as its lead drug candidate ‘Blincyto’ has already obtained breakthrough therapy status and accelerated nod from the U.S. FDA back in 2014, when it was accepted to cure Precursor B-Cell ALL. Last year, the drug was given nod to treat Philadelphia chromosome-negative refractory or relapsed B-cell precursor ALL. In 2015, the drug obtained conditional marketing approval in the EU for treatment of adults with Ph- refractory or relapsed B-cell precursor ALL.
ALL comes in the list of rare but rapidly progressing cancer of the bone marrow and blood list. The median OS stands at 3-5 months in cases of refractory or relapsed ALL. Currently, chemotherapy is the standard cure for refractory or relapsed ALL, and there exists no extensively approved standard therapy regimen.
Dr. Sean E. Harper, the EVP of R&D at Amgen, reported that they are delighted to potentially get full nod for Blincyto. It is the first immunotherapy to record an OS benefit compared to chemotherapy in patients with refractory or relapsed Ph- B-cell precursor ALL, and get a much sought new treatment alternative to those who are Ph+.