This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

U.S. Food And Drug Administration Approves IMBRUVICA™ (ibrutinib) As A Single Agent For Patients With Chronic Lymphocytic Leukemia Who Have Received At Least One Prior Therapy





SUNNYVALE, Calif., Feb. 12, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA (ibrutinib) as a single agent for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. 1 This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. 1 IMBRUVICA is the first once-daily, single-agent, oral kinase inhibitor for patients with CLL who have received one prior therapy 1 and is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

"Rarely does a drug come along with so much potential to help CLL patients," said John C. Byrd, M.D., Director, Division of Hematology, The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital & Richard J. Solove Research Institute and lead investigator for the pivotal CLL trial PCYC-1102-CA. "I have been impressed with the promising and durable response rates we have seen in patients. It is particularly gratifying to see the difference that IMBRUVICA has made for patients in the clinical trials."

CLL is a slow-growing blood cancer of the white blood cells (lymphocytes), most commonly B-cells. 2 CLL is the most common adult leukemia. 3 Approximately 16,000 patients in the U.S. are diagnosed each year with CLL. 4 The prevalence of CLL is approximately 114,500 in the U.S. 5 CLL is a chronic disease that predominantly occurs in the elderly and the average age of diagnosis is 72. 2 Patients commonly receive multiple lines of treatment over the course of their disease. 2 Nearly 4,600 patients die of CLL every year 6 and the five-year survival is approximately 82 percent. 7

IMBRUVICA was approved in CLL for patients who have received at least one prior therapy under the FDA's accelerated approval program. This second indication follows the approval of IMBRUVICA for patients with mantle cell lymphoma (MCL) after one prior therapy on November 13, 2013, granted under the agency's Breakthrough Therapy Designation. 1 Both indications are based on ORR. 1 An improvement in survival or disease-related symptoms has not been established. Most recently IMBRUVICA was included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for Non-Hodgkin's Lymphomas, Version 1.2014 for patients with relapsed/refractory (R/R) MCL and R/R CLL. 6 as a Category 2A recommendation. 8

"Today's approval of IMBRUVICA is the first major milestone in the CLL clinical development plan, which includes seven Phase III trials, four of which are company sponsored, and covers all lines and various combinations of treatments," said Bob Duggan, CEO and Chairman of the Board of Pharmacyclics. "I would like to thank the patients and physicians for their trust and participation in our clinical trials. We are also thankful to the FDA for their collaboration and support, and a very big 'thank you' to the entire Pharmacyclics and Janssen teams who are tirelessly advancing our mission to serve for the betterment of patients."

IMBRUVICA inhibits the function of Bruton's tyrosine kinase (BTK). 1 BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B-cells. 9, 10, 11 IMBRUVICA blocks signals that stimulate malignant B-cells to grow and divide uncontrollably. 1, 12

The approval was based on the results of a Phase Ib/II, open-label, multi-center, international, single-arm trial of 48 patients with relapsed or refractory CLL who received 420mg of IMBRUVICA daily.  The primary endpoint was safety and a secondary endpoint was ORR, which was assessed by a modified version of the International Working Group on CLL (IWCLL) criteria by an Independent Review Committee. 1 The efficacy results demonstrated a 58.3 percent ORR (95% confidence interval (CI) (%), 43.2, 72.4), all partial responses. The duration of response (DOR) ranged from 5.6 to 24.2+ months. The median DOR was not reached.

Safety was evaluated in the same 48 patients, with a median treatment duration of 15.6 months.  The Warnings and Precautions listed in the Prescribing Information include hemorrhage, infections, myelosuppression, renal toxicity, second primary malignancies and embryo-fetal toxicity. 1 The most commonly occurring adverse reactions ( > 20%) in the clinical trial were (listed here as % all Grades, % Grade 3 or 4): thrombocytopenia (71%,10%), diarrhea (63%, 4%), bruising (54%,2% ), neutropenia (54%,27%), anemia (44%,0%), upper respiratory tract infection (48%,26%), fatigue (31%,4%), musculoskeletal pain (27%,6%), rash (27%,0%), pyrexia (25%,2%), constipation (23%,2%), peripheral edema (23%,0%), arthralgia (23%,0%), nausea (21%,2%), stomatitis (21%,0%), sinusitis (21%,6%), and dizziness (21%, 0%).

Five patients (10%) discontinued treatment due to adverse reactions in the trial. These included three patients (6%) with infections and two patients (4%) with subdural hematomas. Adverse reactions leading to dose reduction occurred in thirteen percent of patients. 1 For additional safety information please see below for Important Safety Information and see the full Prescribing Information on the Company's website.

The recommended dose of IMBRUVICA in CLL is 420 mg (three 140 mg capsules) orally once daily. 1

This approval of IMBRUVICA in CLL triggers a $60 million milestone payment to Pharmacyclics under its collaboration agreement with Janssen Biotech Inc.

Corporate Conference Call The Company will hold a conference call today at 2:30 p.m. ET to discuss these events. To participate in the conference call, please dial 1-877-303-7908 for domestic callers and 1-678-373-0875 for international callers. To access the live audio broadcast or the subsequent archived recording, log on to http://ir.pharmacyclics.com/events.cfm. To access a replay of the call please dial 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers and use the conference ID number: 96901967. The archived version of the webcast and conference call will be available for 30 days on the Investor Relations section of the Company's Web site at http://www.pharmacyclics.com.

INDICATIONS IMBRUVICA™ (ibrutinib) is indicated for the treatment of:

  • Patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • Patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

These indications are based on overall response rate. Improvements in survival or disease-related symptoms have not been established.

1 of 5

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 17,122.18 +15.48 0.09%
S&P 500 1,999.66 -0.36 -0.02%
NASDAQ 4,570.0270 -0.61 -0.01%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs