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Amgen Obtains FDA Breakthrough Therapy Designation for BiTE® Antibody Blinatumomab
The Breakthrough Designation Therapy for Investigational BiTE® Antibody Blinatumomab is designated for the treatment of Acute Lymphoblastic Leukemia.
The Breakthrough Therapy Designation was assigned due to significant clinical evidence obtained by the results of a Phase 2 trial of 189 adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab.
"There is a high unmet need for new medicines to treat relapsed and refractory ALL patients, who have very few treatment options," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "The results from the Phase 2 trial evaluating blinatumomab in adult patients with relapsed or refractory ALL are encouraging and provide a strong basis for a regulatory filing later this year and potential approval in this serious disease."
Bispecific T cell Engager (BiTE®) technology is a groundbreaking investigational method that is intended to help engage the body's endogenous T cells to target malignant cells. Blinatumomab is an investigational BiTE® antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. According to Amgen, Blinatumomab is the first of the BiTE antibodies and they have already received orphan drug designation from the FDA for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL).
NOW IS THE TIME TO ENTER INTO THIS WONDERFUL FIELD!
With such industry leaders paving the way with new beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their diversified product portfolio. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently.
CANDIDATES WHO WANT TO BREAK INTO PHARMACEUTICAL SALES!
The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community.
The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions.
Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives(