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Follow on Google News | Pfizer receives FDA Breakthrough Therapy Designation for XALKORI to treat ROS1-positive NSCLCBy: NAPSRx “We are excited that the FDA has granted Breakthrough Therapy designation for XALKORI as a potential treatment for patients with ROS1-positive NSCLC,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. “XALKORI pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which XALKORI has demonstrated a level of anti-tumor activity that can potentially make a real difference for patients.” Established in 2012, the Breakthrough Therapy Designation is intended to accelerate the research and development process for drugs designed to treat serious or life threatening conditions. This designation was awarded to Pfizer based on the global Phase 1 study (Study 1001). According to data published in the New England Journal of Medicine, XALKORI produced effective anti-tumor activity in patients with ROS1-positive advanced NSCLC. The safety profile was also similar to that observed in patients with ALK-positive advanced NSCLC. Pfizer intends to work meticulously with the FDA on the development of XALKORI for ROS1-positive NSCLC with the aim of providing the necessary information to support a potential regulatory submission. CANDIDATES WHO WANT TO BREAK INTO PHARMACEUTICAL SALES! With such industry leaders paving the way on identifying 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 promote their product both proficiently and efficiently. The NAPSRx® is a trade association for pharmaceutical sales reps, sales managers and sales trainers who work in the pharmaceutical industry. NAPSRx® provides Continuing Medical Education to its members as well as CNPR® Certification to candidates who look to enter a pharmaceutical sales career. 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. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives( End
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