Pharmacyclics, Inc. (PCYC) Files sNDA for IMBRUVICA
- Wall Street falls as Apple drags down tech stocks
- Unusual 11 Mid-Day Movers 8/30: (RIGL) (KPTI) (RBA) Higher; (ANF) (CBK) (GIII) Lower
- Apple (AAPL) Determined to Receive Up to EUR13 Billion in Undue Irish Tax Breaks - EC
- Bill Ackman Baked Into a Corner on Herbalife (HLF), Icahn Tells CNBC
- Agrium (AGU), PotashCorp (POT) Confirm Merger Talks; Say No Decision Made
Pharmacyclics, Inc. (NASDAQ: PCYC) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multi-center, open-label Phase III RESONATETM study, PCYC-1112, a head-to-head comparison of single agent IMBRUVICATM (ibrutinib) versus ofatumumab in 391 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.
At a planned interim analysis in January 2014, the results of the RESONATE study demonstrated a statistically significant improvement in progression-free survival, the primary endpoint of the study, in patients treated with IMBRUVICA. Further, patients in the IMBRUVICA arm also showed a statistically significant improvement in overall survival, a key secondary endpoint of the trial. The safety profile of IMBRUVICA was acceptable and showed a favorable risk benefit profile. Data from this study will be discussed in a presentation at the 50th annual meeting of the American Society of Clinical Oncology in Chicago, May 30 – June 3, 2014.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Kamada's (KMDA) Inhaled Alpha-1 Antitrypsin Phase 2 Met Primary Endpoint
- Cynapsus (CYNA) Announces Receipt of FDA Fast Track Designation for APL-130277 as OFF Episodes Treatment in PD Patients
- Regeneron (REGN), Sanofi (SNY) Announce Significant Results from Praluent Phase 3 in HeFH Patients
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot Corp. News
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!