NAPSR News: FDA Approves Keytruda to treat Advanced Melanoma

Sept. 5, 2014 - PRLog -- The FDA accelerated approval of Keytruda represents a landmark achievement for Merck as it is the first approved drug blocking a cellular pathway known as PD-1. PD-1 is known to restrict the immune system’s ability from attacking melanoma cells.

Keytruda is intended to be used after immunotherapy treatment ipilimumab. Keytruda should be used after treatment with ipilimumab and a BRAF inhibitor (therapy that blocks activity of BRAF gene mutations) in melanoma patients whose tumors express a gene mutation called BRAF V600

“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.”

Keytruda was granted FDA Breakthrough therapy due to substantial clinical evidence of improvement over other therapies. It also received priority review and orphan product designation. Priority review is established for therapies that are potentially effective to treat serious conditions at the time the application was submitted. Orphan product designation is given to drugs intended to treat rare diseases.  The approved indication of Keytruda was based on tumor response rate and durability of response.

“The accelerated FDA approval of KEYTRUDA is a meaningful development for patients with advanced melanoma,” said Dr. Omid Hamid, Director of the Melanoma Center at The Angeles Clinic and Research Institute, and a principal investigator for the pembrolizumab melanoma clinical program. “Our new ability to target the PD-1 pathway with KEYTRUDA is a very exciting step in the immunotherapy field.”

Keytruda is marketed by Merck & Co., based in Whitehouse Station, New Jersey.

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(NAPSRx) for more information or visit the website at http://napsronline.org/.