Amgen, Inc. (NASDAQ:AMGN) announced with pride today, that the company has submitted the relevant forms for a supplemental biologics licence, which will be instrumental, for their upcoming drug BLINCYTO.
The relevant application forms were submitted to the U.S Food And Drug Administration. In this application, the company did list various results from the trial, which should aid in supporting the full approval of the drug, for retail purposes.
The treatment opportunities BLINCYTO will introduce
BLINCYTO in question was developed primarily for the treatment in relapsed, and even Refractory B-cell precursor acute lymphoblastic Leukaemia. Through this application, the company intends to further expand the overall number of patients, that it will be able to introduce this drug too.
This drug has been vigorously tested, which is one of the main reasons, the company is almost certain that it will be approved by the U.S Food And Drug Administration. In the application, there were also reports of the efficiency of the drug in the recent Phase 3 Tower Study, to which it was induced.
The Tower 3 study, revealed the comparative efficiency between this drug, and the normal treatments of chemotherapy, for patients with refractory b-cell precursor symptoms. However, the downfall of this drug is that it has warnings for adverse side-effects, such as Cytokine Release Syndrome (CRS).
The development of BLINCYTO and comments from those well-versed in the matter
This breakthrough drug was first granted accelerated approval in December 2014. However, there is more to this drug, with a few landmarks in terms of treatment awards. For example, it is the first drug, to be FDA-approved bispecific CD 19-directed CD3 T cell engager antibody.
When questioned on the matter, an executive vice president, responsible for research and development, Sean E. Harper, M.D., stated, “Acute lymphoblastic leukemia is one of the most aggressive B-cell malignancies, and adult patients who relapse or are refractory to treatment often go through multiple lines of therapy, which can now be prevented.”