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 Investor Update - Category: Pharmaceuticals Source Type: news

Related Links:

Dalton Trans., 2021, Advance Article DOI: 10.1039/D1DT01460A, PaperLiping Qiao, Jiangping Liu, Shi Kuang, Xinxing Liao, Junfeng Kou, Liangnian Ji, Hui Chao A mitochondria-targetedBODIPY-Ir(III) conjugate acted as a photoinduced ROS generator and exerted high oxidative lethality towards triple-negative breast cancer cells at an ultralow concentration under irradiation. To cite this article before page numbers are assigned, use the DOI form of citation above. The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Dalton Trans. latest articles - Category: Chemistry Authors: Source Type: research
But rates higher for infection - related cancers, such as liver and stomach cancers, and cervical cancer
Source: The Doctors Lounge - Oncology - Category: Cancer & Oncology Tags: Dermatology, Family Medicine, Gastroenterology, Gynecology, Infections, Internal Medicine, Nephrology, Oncology, Ophthalmology, ENT, Pulmonology, Urology, Journal, Source Type: news
Progression - free survival longer with T - DXd versus T - DM1 for HER2+ metastatic breast cancer previously treated with trastuzumab and taxane
Source: The Doctors Lounge - Oncology - Category: Cancer & Oncology Tags: Gynecology, Oncology, Pharmacy, Conference News, Source Type: news
Findings seen for screening - detected breast cancer, but not interval cancer risk
Source: The Doctors Lounge - Oncology - Category: Cancer & Oncology Tags: Gynecology, Oncology, Radiology, Journal, Source Type: news
Source: BMJ Comments - Category: General Medicine Source Type: forums
Skewed drug metabolism of 6-mercaptopurine (6-MP) can jeopardize antileukemic effects and result in toxicities during the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Allopurinol can alter 6-MP metabolism to maximize therapeutic effects while reducing toxicities. Over 75% of our patients with acute lymphoblastic leukemia or lymphoblastic lymphoma experienced a 6-MP-related toxicity. Review of metabolite date a showed 6-methylmercaptopurine nucleotide levels were>10,000 in 55% of the cohort, suggesting 6-MP shunting. Allopurinol was initiated in 12 of 23 shunters with resolution of toxicities. We...
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
Conclusion: Fever due to HDAC is relatively common but appears to frequently lack association with bacteremia during the time of HDAC administration. Broad-spectrum empiric antibiotic regimens including vancomycin may be unnecessary for these patients, particularly before they become neutropenic.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
We describe a successfully diagnosed and treated CHL-PTLD stage IV pediatric patient, 8 years after liver transplantation. The patient was treated with standard CHL (Children’s Cancer Group 5942 group 3) chemotherapy, rituximab and reduction of immunosuppressant. The patient remains in complete remission after 3 years with stable graft function. To our best knowledge, this is the first pediatric case report of a successfully treated stage IV CHL-PTLD after a liver transplant.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
Conclusions: In Argentina, we did not show significant differences in outcomes between MSD and MUD HSCT for children with high-risk leukemia. Future work should focus on strategies to reduce the relapse risk in children with high-risk leukemia in upper-middle-income countries.
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
Hepatitis-associated aplastic anemia (HAAA) has been reported in 23% to 33% of patients who received orthotopic liver transplantation (LT) for acute liver disease of unknown origin (nonviral hepatitis). In this situation, hematopoietic stem cell transplantation (HSCT) might be a curative option. Here the authors report on 6 patients who received HSCT after LT for nonviral HAAA hepatitis. The outcomes were interpreted in the context of recently reported immune suppressive therapy (IST) outcomes in 8 patients with HAAA and to HSCT outcomes in patients with HAAA who recovered from hepatitis without undergoing LT. All patients...
Source: Journal of Pediatric Hematology Oncology - Category: Hematology Tags: Online Articles: Clinical and Laboratory Observations Source Type: research
More News: Acute Leukemia | Acute Myeloid Leukemia | Allergy & Immunology | Anemia | Biotechnology | Cancer | Cancer & Oncology | Chemotherapy | Chronic Leukemia | Chronic Lymphocytic Leukemia | Clinical Trials | Diabetes | Endocrinology | Food and Drug Administration (FDA) | Grants | Infectious Diseases | International Medicine & Public Health | Leukemia | Lymphoma | Myelodysplastic Syndrome | Opthalmology | Partnerships | Pharmaceuticals | Primary CNS Lymphoma | Rituxan | Science | Study | WHO