Pharmacyclics, Inc. (PCYC) Files sNDA for IMBRUVICA
- Top 10 News for 10/5 - 10/9: Twitter Names New CEO; Fed Cautious on Hike Amid Global Slowdown; GE Gets New Activist
- Wall Street ekes out small gain to cap strongest week of year
- DSV to Acquire UTi Worldwide (UTIW) in $1.35B Deal
- SolarWinds (SWI) Commences Review of Strategic Alternatives
- Barclays Downgrades Tesla Motors (TSLA) to Underweight
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
- Bristol-Myers Squibb (BMY) Affirms FDA Approval of Opdivo Injection as Metastatic NSCLC Treatment
- International Paper (IP) Gains After Announcing Plans to Exit Chinese Coated Board JV
- UPDATE: Wal-mart (WMT) Appoints Brett Biggs as EVP, CFO; Charles Holley to Retire
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!