AstraZeneca's new lymphoma drug acalabrutinib is recognized as a breakthrough therapy

Source: Wuxi apptec 2017-08-02 today, AstraZeneca and acerta Pharma, the center of Hematology Research and development excellence, announced that the US FDA has issued a breakthrough treatment certification to its new drug under development, acalabrutinib, for patients with mantle cell lymphoma (MCL) who have received at least one treatment This is also the second breakthrough treatment identified by AstraZeneca this week, after the PD-L1 inhibitor imfinzi was identified as breakthrough therapy yesterday It is worth mentioning that this is the first breakthrough treatment recognition of AstraZeneca in the field of blood cancer treatment! Mantle cell lymphoma (MCL) is a highly invasive B-cell non-Hodgkin's lymphoma (NHL) with a poor prognosis The treatment of this malignant disease is also a goal of new blood cancer researchers Acalabrutinib is a highly selective and potent covalent inhibitor of Bruton tyrosine kinase (Btk), with minimal non targeting activity observed in preclinical trials The new drug under development is expected to be used in the treatment of multiple B-cell carcinoma and other cancers Acalabrutinib's development projects include single drug and combination therapy for chronic lymphoblastic leukemia (CLL), MCL, Fahrenheit megaglobulinemia (WM), follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), multiple myeloma, and single drug and joint trials for solid tumors In total, there are more than 2000 patients and more than 25 clinical trials using acalabrutinib are in progress or have been completed In September 2015, acalabrutinib was awarded orphan drug qualification by FDA to treat MCL, and in March 2016, it was awarded orphan drug qualification by European Commission to treat CLL, MCL and WM The FDA's breakthrough treatment is based on good clinical data from acalabrutinib in a phase 2 clinical trial called ace-004 This recognition can speed up the development and evaluation of new drugs, and is expected to accelerate the marketing process of this new drug for the treatment of serious diseases Dr Sean bohen, global drug development and chief medical officer of AstraZeneca, said: "for those MCL patients who are not in remission in the current treatment, new treatment is imminent Acalabrutinib's groundbreaking treatment determination will help us bring this potential new drug to patients in need as soon as possible " "This is an exciting milestone for us in hematology," said Dr Flavia borellini, CEO of acerta pharma Acalabrutinib is an effective and irreversible Btk inhibitor with high specificity for its target If approved, patients with this catastrophic disease may have new options for clinically significant treatment "