IMBRUVICA™ (ibrutinib) now approved in the U.S. for patients with chronic lymphocytic leukemia who have received at least one prior therapy

Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.¹ IMBRUVICA was first approved in November 2013 for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.¹ Both indications are based on an 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 Bruton’s tyrosine kinase (BTK) inhibitor for patients with CLL who have received one prior therapy and is being jointly developed and commercialized by Janssen and Pharmacyclics, Inc. Both indications were granted priority review and were approved under the FDA’s accelerated approval program; in addition, IMBRUVICA is one of the first medicines with the FDA’s Breakthrough Therapy Designation to receive U.S. approval.

CLL is a slow-growing blood cancer of white blood cells called lymphocytes, most commonly B cells.² CLL is an orphan disease (which is defined as a disease impacting fewer than 200,000 Americans³) and is primarily diagnosed in those over 70 years old.² In the U.S., an estimated 16,000 people are diagnosed with CLL each year⁴ and it is estimated that nearly 4,600 will unfortunately die due to this disease.⁵ The U.S. prevalence of CLL is approximately 114,500 people.⁶

“CLL is a challenging disease and many physicians switch their patients from therapy to therapy as their disease relapses. There has been a significant need for new alternatives for these 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 pivotal CLL trial PCYC-1102-CA.† “The approval of IMBRUVICA provides a new, once-daily oral therapy option for physicians.”

“The speed at which we were able to bring IMBRUVICA to this point epitomizes the sense of urgency that drives oncology drug developers to bring important new medicines to patients in need,” said Craig Tendler, M.D., vice president, Late-Stage Development and Global Medical Affairs for Oncology, Janssen. “We’re delighted and proud of today’s approval, because it represents our commitment to making a difference for patients. We appreciate the ongoing collaboration between the companies and the FDA, which made this possible.”

IMBRUVICA works by blocking a specific protein called BTK.¹ Non-clinical studies have shown that blocking BTK inhibits the enzyme needed by the cancer to multiply and spread.¹

1.  IMBRUVICA Prescribing Information, February 2014[2] American Cancer Society. Detailed guide: what is chronic lymphocytic leukemia. Available from: http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf Accessed January 2014.000
3. National Organization for Rare Disorders. “Rare Disease Information”. Available from: http://www.rarediseases.org/rare-disease-information/rare-disease-information. Accessed January 2014.
4. National Cancer Institute. What You Need To Know About™ Leukemia. Available from http://www.cancer.gov/cancertopics/wyntk/leukemia/page4. Accessed January 2014.
5. National Comprehensive Cancer Network. NCCN Guidelines Version 1.2014: Non-Hodgkin’s Lymphomas. Available from: http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf. Accessed January 2014.
6. IMS patient claims estimates for July 2012-June 2013. Note: This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: IMS Oncology Tracking Reports for the period July 2012 to June 2013. IMS expressly reserves all rights, including rights of copying, distribution and republication. Pharmacyclics, Inc. makes no representation with respect to the accuracy or reliability of this information. Investors are advised toindependently verify this information before using it to make investment decisions.