FDA grants Breakthrough Therapy Designation for Venclexta in combination with azacitidine for the treatment of patients with myelodysplastic syndromes

Basel, 21 July 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Venclexta ® (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes (MDS) based on the rev ised International Prognostic Scoring System (IPSS-R). MDS are a rare group of blood cancers that gradually affect the ability of the bone marrow to produce normal blood cells.2 This can lead to weakness, frequent infections, anaemia and debilitating fatigue.3 In some cases, MDS can also progress into acute myeloid leukaemia (AML).4,5 Every year in the US, approximately 10,000 people are diagnosed with MDS, and the median survival for those with higher-risk MDS is approximately 18 months.1,3“Higher-risk MDS is associated with poor prognosis, reduced quality of life, and limited treatment options,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased that the FDA has granted Venclexta its sixth Breakthrough Therap y Designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.”This designation was granted based on interim results from the phase Ib M15-531 study investigating Venclexta/Venclyxto plus azacitidine in people with previously untreat...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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This article is licensed under aCreative Commons Attribution-NonCommercial 3.0 Unported Licence.Bjoern C Froehlich, Robert Popp, Constance A Sobsey, Sahar Ibrahim, Andre M LeBlanc, Yassene Mohammed, Marguerite Buchanan, Adriana Aguilar-Mahecha, Oliver Poetz, Michael X Chen, Alan Spatz, Mark Basik, Gerald Batist, Rene Zahedi, Christoph H. Borchers The PI3-kinase/AKT/mTOR pathway plays a central role in cancer signaling. While p110 α is the catalytic α-subunit of PI3-kinase and a major drug target, PTEN is the main negative regulator of... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Analyst latest articles - Category: Chemistry Authors: Source Type: research
ConclusionsThis systematic review suggests that women with HPV- and p16-positive vaginal cancer have an improved prognosis compared with those with HPV- or p16-negative vaginal cancer. Results for p53 were varied, and no conclusion could be reached. Only 12 studies could be included in the review, of which most were based on small populations. Hence, further and larger studies on the prognostic impact of HPV, p16, and p53 in vaginal cancer are warranted.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: SYSTEMATIC REVIEW Source Type: research
This study aims to detail the characteristics of chemotherapy-related acute kidney injury (CR-AKI) and investigate its effect on patient outcomes.MethodsThis is a multicenter cross-sectional study of cancer patients with CR-AKI screened from hospital-acquired adult AKI patients based on a nationwide AKI survey in China.ResultsOf the 3468 patients with hospital-acquired AKI, 258 cases of CR-AKI were identified. Of the patients, 20.1% (52/258) were ≥ 70 years old. Among the 258 CR-AKI cases, 61 (23.6%) reached AKI stage 3, and 75 (29.1%) reached AKI stage 2. The remaining 122 (47.3%) remained at AKI stage 1. A total of 41...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
In CMML, neoplastic monocytes can be distinguished based on their immunophenotype. Supportive care myeloid growth factors in concomitant extranodal non-Hodgkin Lymphoma are safe. AbstractIn CMML, neoplastic monocytes can be distinguished based on their immunophenotype. Supportive care myeloid growth factors in concomitant extranodal non-Hodgkin Lymphoma are safe.
Source: Clinical Case Reports - Category: General Medicine Authors: Tags: CASE REPORT Source Type: research
ConclusionsChemotherapy with FOLFIRNOX or gemcitabine/nab-paclitaxel induces variable changes in circulating T-cell populations that may provide prognostic information in PDAC.
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
AbstractMethylation of N6-adenosine (m6A) is the most prevalent internal RNA modification and is especially common among the messenger RNAs. These m6A modifications regulate splicing, translocation, stability and translation of RNA through dynamic and reversible interactions with m6A-binding proteins, namely the writers, erasers and readers. RNA methyltransferases catalyze the m6A modifications, while demethylases reverse this methylation. Deregulation of the m6A modification process has been implicated in human carcinogenesis, including melanoma —which carries one of the highest mutant rates. In this review, we prov...
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
ConclusionPelvic floor dysfunction commonly deteriorates and negatively impacts on quality of life after minimally invasive radical hysterectomy, especially bowel function after TMMR. Pelvic floor symptoms should routinely be addressed pre- and postoperatively.
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
AbstractCancer genomics has evolved over the years from understanding the pathogenesis of cancer to screening the future possibilities of cancer occurrence. Understanding the genetic profile of tumors holds a prognostic as well as a predictive value in this era of therapeutic surveillance, molecular remission, and precision medicine. Identifying molecular markers in tumors is the current standard of approach, and requires an efficient combination of an accessible sample type and a profoundly sensitive technique. Liquid biopsy or cell-free DNA has evolved as a novel sample type with promising results in recent years. Althou...
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
ConclusionTaken together, miR-143-3p and miR-495-3p co-target CDK1, thereby inhibiting the occurrence and development of cervical cancer.
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
AbstractObjectivesHigh-risk human papillomavirus (HR-HPV) is an important risk factor for esophageal cancer. Macrophages constitute a crucial immune medium for regulating HPV-related tumors; however, the specific regulatory mechanisms remain unknown. Therefore, the purpose of our current study was to investigate the mechanism by which HPV16E6 regulates macrophages to promote the invasion and metastasis of esophageal cancer.MethodsHPV16E6 infection was detected by polymerase chain reaction. Immunohistochemistry was used to verify the distribution of tumor-associated macrophages (TAMs) and MMP-9 expression in esophageal squa...
Source: Clinical and Translational Oncology - Category: Cancer & Oncology Source Type: research
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