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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.

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