[1] Specifikt är det för personer som tidigare hade behandlats med en annan terapi. An FDA BTD is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically-significant endpoint over currently-available medicines.ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of The primary endpoint is progression-free survival (PFS) in the ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Chronic lymphocytic leukaemia (CLL) is one of the most common type of leukaemia in adults, with an estimated 105,000 new cases globally and 20,720 new cases in the US annually, and prevalence that is expected to grow with improved treatment.Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio ofnew medicines that has the potential to transform patients’ lives and the Company’s future.

Copy this html code to your website/blog to embed this press release. PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids. Calquence is also expected to duke it out with its fellow BTK inhibitor in chronic lymphocytic leukemia, which represents a larger market opportunity. Read more on. De vanligaste biverkningarna var huvudvärk, diarré och viktökning. AstraZeneca PLC is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its global headquarters in Cambridge, England. For more information, please visit

So a USA doctor would probably be reluctant to prescribe it off label and treatment naive, when Ibrutinib is nearly the gold standard for previously untreated CLL in the USA. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Acalabrutinib has not been associated with serum enzyme elevations during therapy or with cases of idiosyncratic acute liver injury, but has been linked to cases of reactivation of hepatitis B. Acerta Pharma serves as AstraZeneca’s haematology research and development arm.
Acalabrutinib is an oral inhibitor of Bruton’s tyrosine kinase that is used in the therapy of B cell malignancies including refractory mantle cell lymphoma. ELEVATE TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. 1. To prevent automated spam submissions leave this field empty.To prevent automated spam submissions leave this field empty. A review by EMA’s safety committee (PRAC) has confirmed that 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids can cause liver injury, including the need for liver transplantation.
Next, in 2017, the FDA approved Calquence (acalabrutinib), an agent that has been shown to induce comparable overall response rates with potentially less risk for atrial fibrillation and bleeding. The Company’s haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Efter lovande resultat för KLL i initiala kliniska försök, så köpte Jämfört med ibrutinib så demonstrerade acalabrutinib högre selektivitet och hämning av den riktade aktiviteten av BTK, medan den har en mycket större IC Delresultaten av den fortfarande pågående första kliniska prövningen av den första mänskliga fasen 1/2 (NCT02029443) med 61 patienter för behandling av återfall av Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia.Acalabrutinib (ACP-196): a selective second-generation BTK inhibitorAcalabrutinib (ACP-196): a selective second-generation BTK inhibitor The Breakthrough Therapy Designation acknowledges the growing body of evidence that supports The FDA granted the BTD based on positive results from the interim analyses of the This is the 10th BTD that AstraZeneca has received from the FDA since 2014. I don't believe that Calquence/Acalabrutinib is approved for CLL (yet) only previuosly treated Mantel Cell Lymphoma. With at least six new medicines to be launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. Acalabrutinib (handelsnamn Calquence) är ett läkemedel som används för att behandla en typ av icke-Hodgkin-lymfom som kallas mantelcellymfom.

Från och med februari 2016 hade Acalabrutinib fått en Det utvecklades av Acerta Pharma. AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for José Baselga, Executive Vice President, Oncology R&D, said: “This is an important regulatory milestone for our work in haematology and for patients living with chronic lymphocytic leukaemia, a life-threatening disease. AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukaemia (CLL), one of the most common types of leukaemia in adults.


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