Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers March 27, 2017
Pharmacy Choice - Pharmaceutical News - Array BioPharma Withdraws NDA For Binimetinib Monotherapy - March 27, 2017

Pharmacy News Article

 3/20/17 - Array BioPharma Withdraws NDA For Binimetinib Monotherapy

WASHINGTON (dpa-AFX) - Array BioPharma Inc. (ARRY) said that it has withdrawn from the U.S. Food and Drug Administration's Division of Oncology Products 2 its new drug application or NDA for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.

The action was based on thorough discussions and communications with the FDA, including exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on Friday, March 17, 2017. Based on feedback from the agency, Array concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA.

Ongoing clinical trials for binimetinib will continue. This action will not impact the planned Phase 3 COLUMBUS trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.



Copyright RTT News/dpa-AFX

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

LIVE ONLINE CE

Last Chance
Mar 27: HIV Medications: Newer Drugs, Newer Guidelines
Last Chance
Mar 28: Adverse Drug Events: Risk Reduction and Reporting
Mar 30: Know Your Value, Know Your Worth: Provider Status in Pharmacy
Mar 31: Medication Safety & Drug Safety Alerts
Apr 03: Headache Disorders: Focus on Migraines & Tension Headaches
Click for entire Webinar Calendar

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...

Nursing Jobs
Are you a nurse looking for a job?

Check out the Nursing Job Source.

Your number one choice for nursing jobs.



Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415