After a Priority Review by the Center for Drug Evaluation (CDE) in December 2016, IMBRUVICA® was approved by the CFDA on August 24, 2017, and is now available on the market 69 days later, thereby providing an effective treatment option for Chinese blood cancer patients. The accelerated market launch of IMBRUVICA® would have been impossible without the government's expedited review and approval.
“CLL/SLL and MCL are two rare diseases with high rates of recurrence, but there have been few treatment options in China,” said Professor Ma Jun, Chairman of the Union for China Lymphoma Investigators (UCLI) and Director of the Hematology & Oncology Hospital of Harbin Medical University. “Due to the paucity of new medications in the past 8 years, most patients who relapse or develop resistance to therapy have had no alternative options. Therefore, both patients and doctors alike are urgently seeking a well-tolerated and effective alternative.”
Professor Zhou Daobin of the department of hematology of Peking Union Medical College Hospital, adds, “CLL is a chronic disease with an overall five-year survival rate of 70 percent , but it remains incurable, and the overall survival is always less than two to three years if the disease returns. ”
Professor Jiang Wenqi from the Department of Medical Oncology, Sun Yat-sen University Cancer Center added, “In recent years, progress has been made in the treatment of MCL, but it is still a high-fatality malignancy and for a long time there have been no new treatment options. Patients with MCL temporarily respond to chemotherapy and, due to a high recurrence rate, their long-term prognosis is poor. The median overall survival for MCL is typically three to four years, and only one to two years following the first relapse. ”
IMBRUVICA® is taken orally, once a day, and is the first in a new class of medicines called Bruton’s Tyrosine Kinase (BTK) inhibitors. It provides a much-needed treatment option for Chinese patients suffering from CLL/SLL and MCL. Its efficacy and safety were evaluated in five international phase 2/3 trials, including an Asia-Pacific phase 3 trial.
Clinical trials targeted at Chinese patients as well as multi-regional clinical trials show that for patients suffering from CLL/SLL who have received at least one prior therapy, the risk of progression or death after treatment with ibrutinib is reduced by about 80% , , which means that their median survival expectancy is close to that of healthy people in the same demographic. In an international multi-center, open label single trial, 111 MCL patients who had previously received at least one treatment, received ibrutinib, and the overall response rate (ORR) reached 65.8% . A five years follow-up study showed that CLL/SLL patients who had received at least one prior therapy, received ibrutinib, and as a result the overall response rate (ORR) reached 89%, the median progression free survival (PFS) was 52 months, and the overall survival (OS) achieved 57%.
“Clinical data demonstrate clearly that compared to existing treatment options, ibrutinib can help prolong life, and it is also well tolerated,” said Li Bin, Head of Medical Affairs, Xian Janssen Pharmaceutical Ltd. “Furthermore, ibrutinib is convenient to take orally once a day, which is significant in terms of quality of life,” he added.
“Xian Janssen is committed to fulfilling the unmet needs of Chinese patients with innovative treatments,” said Asgar Rangoonwala, President of Xian Janssen Pharmaceuticals Ltd. “We know that blood cancer patients are waiting, and we have been making every effort to accelerate the launch of IMBRUVICA®, in order to make this treatment option accessible in China. Today’s launch is just the first step in this effort. In the future, we will continue to fulfill our patient-centric commitment, facilitating access and bringing hope through multi-party cooperation and innovation."
“The launch of IMBRUVICA® has brought new hope for patients who suffer from these two types of blood cancer,” said Mr. Hong Fei, founder of House086, a lymphoma patient group in China. “We would like to thank the government for granting priority review of this effective and urgently needed medicine. We also want to thank Xian Janssen for introducing IMBRUVICA® to China. We hope that IMBRUVICA® will be included in the National Reimbursement Drug List soon, so that more patients can benefit from this innovative treatment.”
At present, IMBRUVICA® is available in 49 cities in China. The China Primary Health Care Foundation has launched the IMBRUVICA® Patient Assistant Program to provide IMBRUVICA® (ibrutinib) assistance to low-income patients.
IMBRUVICA® was co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen will market IMBRUVICA® in China, and Janssen operating companies are marketing it around the world, except for in the United States, where Pharmacyclics, LLC and Janssen Biotech Inc. co-market IMBRUVICA®. By the end of August 2017, IMBRUVICA® (ibrutinib) was approved in 86 countries, and has been used to treat more than 90,000 patients world-wide. In 2015, IMBRUVICA® (ibrutinib) was awarded the prestigious Prix Galien USA 2015 Award in the category of Best Pharmaceutical Agent.