On February 25, the reporter learned from Beijing BeiGene that the U.S. Food and Drug Administration (FDA) accepted Baiyueze® (zanubrutinib) for the treatment of adult chronic lymphocytic leukemia on February 22. (CLL) or small lymphocytic lymphoma (SLL) patients with a new indication marketing authorization application (sNDA). Under the Prescription Drug Filer Fee Act (PDUFA), the FDA target date for a decision is October 22, 2022.
Meanwhile, the European Medicines Agency (EMA) has also accepted two new indications for zanubrutinib for the treatment of patients with chronic lymphocytic leukemia (CLL) and patients with marginal zone lymphoma (MZL). application for a marketing authorisation for the disease.
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in Western countries, and CLL accounts for about a quarter of new leukemia cases, with more than 21,000 new cases in the United States in 2021. Small lymphocytic lymphoma (SLL) is a type of non-Hodgkin’s lymphoma that affects B lymphocytes of the immune system. It shares many similarities with CLL, but the tumor cells are more often found in the lymph nodes.
Zabrutinib is a small molecule inhibitor of BTK independently developed by BeiGene. In November 2019, zanubrutinib was approved for the first time in the world in the United States, achieving a “zero breakthrough” in China’s new anti-cancer drugs, and subsequently it was approved for marketing in China, Canada, Australia, Russia, the European Union and other countries and regions. , and its commercial footprint has spread to 44 markets around the world. In addition, there are still more than 40 drug regulatory filings under review globally.
“This round of substantial progress in the expansion of new indications in the European and American markets is another important milestone for BeiGene in the global drug regulatory registration program.” Chief Hematology Department of BeiGene Huang Weijuan, medical officer, said that this means that the clinical application of zanubrutinib will continue to expand. In addition, in the latest National Comprehensive Cancer Network (NCCN) guidelines, zanubrutinib was listed as a preferred first-line or later-line recommended treatment for CLL/SLL, marking its international recognition in this important indication for CLL. Guideline recommendation status has risen significantly.
The reporter noticed that on January 28, before the European and American acceptance of zanubrutinib’s new indication marketing authorization application, the review center of China’s State Food and Drug Administration had accepted zanubrutinib for the first time. The marketing authorization application for a new indication for the treatment of patients with CLL or SLL, and the grant of breakthrough therapy designation to Baiyueze, will accelerate its promotion as a first-line treatment option. In China, Baiyueze has three approved indications included in the National Medical Insurance List. After another price cut after the latest medical insurance negotiation, it has now become the product with the lowest monthly treatment cost of similar BTK inhibitors in China.
BeiGene’s globalization is also accelerating. On February 24, Yan Xiaojun, senior vice president of BeiGene and head of global drug administration affairs, revealed to reporters that as of January 2022, BeiGene has conducted more than 100 clinical trials worldwide, covering more than 45 clinical trials. Countries and regions, of which 38 are Phase III or potentially registrational clinical trials. “We have now enrolled more than 14,500 patients globally, nearly half of whom are overseas.”