Spectrum Pharma (SPPI) Says FDA Advisory Committee Votes that Qapzola Has Not Shown Substantial Evidence of Treatment Effect Over Placebo
- Donald Trump Sworn in as 45th U.S. President
- Wall Street ends higher as Trump becomes president
- Walgreens Boots Alliance (WBA) Said to Face Antitrust Concern for Rite Aid (RAD) Fix - Bloomberg
- Bristol-Myers Squibb (BMY) Says It Won't Pursue Accelerated U.S. Regulatory Pathway for Opdivo Plus Yervoy in Lung Cancer
- Apple (AAPL) Sues Qualcomm (QCOM) Over Patent Royalties in Antitrust Case - Bloomberg
Get the Pulse of the Market with StreetInsider.com's Pulse Picks. Get your Free Trial here.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC).
The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is December 11, 2016.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Synergy Pharmaceuticals (SGYP) PT Raised to $18 at Rodman & Renshaw Following FDA Approval
- Minerva Neurosciences (NERV) Reports Additional Data Analyses From Phase IIb Trial of MIN-101 in Schizophrenia
- Voyager Therapeutics (VYGR) Offers Update on Phase 1b Trial of VY-AADC01 for Advanced Parkinson's Disease
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesDefinitive Agreement, PDUFA, AdCom
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!