News By Tag
News By Location
NAPSR news: FDA grants regular approval of IMBRUVICA to treat chronic lymphocytic leukemia
IMBRUVICA®, a jointly developed therapy from Pharmacyclics, Inc. and Janssen Biotech received full Approval based on Phase 3 RESONATE™ study data
The Phase III RESONATE™ study (PCYC-1112-CA)
"IMBRUVICA demonstrated substantial evidence of its superiority over ofatumumab and significant benefit for previously treated CLL patients, while maintaining a favorable safety profile. This FDA approval for IMBRUVICA is a major step toward chemo-free treatment in CLL," said John Byrd, M.D.,* Director, Division of Hematology, The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital & Richard J. Solove Research Institute and lead investigator for RESONATE. "Patients with deletion 17p CLL are at particularly high risk for poor outcomes. Today's approval of IMBRUVICA provides these patients with the only FDA-approved treatment, regardless of whether their disease is treatment naïve or previously treated. I continue to be awed by the duration of my patients' responses to IMBRUVICA and am grateful IMBRUVICA now is available to a broader group of CLL patients."
Chronic lymphocytic leukemia (CLL) is a type of cancer of the white blood cells and occurs when the bone marrow makes too many abnormal white blood cells, or lymphocytes, that never become healthy, infection-fighting cells. It is the second most common form of leukemia in adults and is the most common adult leukemia in the Western world usually affecting the elderly with a median age at diagnosis of 72 years. “We are delighted IMBRUVICA has received full approval by demonstrating its ability to improve progression-
IMBRUVICA is being jointly developed and commercialized by Pharmacyclics, Inc. and Janssen Biotech, Inc. Both companies will continue further research by establishing an extensive clinical development program for IMBRUVICA, which includes Phase 3 study commitments in multiple patient populations.
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 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 market 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(