Amgen Inc. (AMGN, Financial) announced March 29 that the U.S. Food and Drug Administration granted its supplemental Biologics License Application for Blincyto (blinatumomab) priority review.Â
In the application, the California-based biopharmaceutical company sought to include the overall survival data from the phase 3 TOWER study.
Blincyto, the brand name under which Blinatumomab is sold, is used to treat acute lymphoblastic leukemia (ALL) when it has come back or has not responded to previous treatments. Blincyto is used in patients affected with Philadelphia chromosome negative (Ph-). This means some of their genes have not been reorganized to form a special chromosome called the "Philadelphia chromosome," named in honor of the U.S. city where it was discovered, which is present in some patients with ALL.
B-cell precursor acute lymphoblastic leukemia (ALL) is a type of blood cancer in which too many B-cell lymphoblasts (immature white blood cells) are found in the blood and bone marrow.
Given the small number of ALL patients, this particular form of blood cancer is categorized as a rare disease.
Amgen says the application also includes new data that supports the treatment of patients affected with “Philadelphia chromosome-positive relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL).”
The company says once the application is approved, Amgen will expand the indication of Blincyto to include all patients affected with relapsed or refractory B-cell precursor ALL and “supports the conversion of the biologic's accelerated approval to full approval.”
Dr. Sean E. Harper, Amgen executive vice president of research and development, said, “Patients with relapsed or refractory ALL generally have a very poor prognosis. The median overall survival – or OS – on standard of care chemotherapy is just four months. Blincyto is the first and only approved bispecific immunotherapy with superior OS results versus standard of care chemotherapy, nearly doubling the median OS for patients with this form of ALL. We look forward to making this important potential new option available to patients with all forms of relapsed or refractory B-cell ALL.”
The FDA is expected to respond by Aug. 14.
The FDA first approved Blincyto in December 2014.
Amgen is currently trading around $164.38 per share, up $1.32 or 0.81% from the previous trading day, with a price-sales ratio of 5.27 and a price-book ratio of 4.06. The forward price-earnings ratio is 12.91.
Disclosure: I have no positions in Amgen Inc.
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