Myeloid sarcoma

Kronos Bio Announces FDA Clearance of Investigational New Drug Application for Lanraplenib (LANRA) for Treatment of Patients with Acute Myeloid Leukemia (AML)

Retrieved on: 
Tuesday, July 27, 2021

SAN MATEO, Calif. and CAMBRIDGE, Mass., July 27, 2021 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for lanraplenib (LANRA), allowing the company to proceed with a Phase 1/2 clinical trial of LANRA in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML) in combination with gilteritinib. Kronos Bio expects to initiate the trial in the fourth quarter of this year. The company is developing LANRA as a next-generation spleen tyrosine kinase (SYK) inhibitor, with improved pharmacokinetic (PK) and pharmacologic properties compared with entospletinib (ENTO), the company’s lead program. ENTO will be evaluated in combination with standard chemotherapy in a planned Phase 3 clinical trial in patients newly diagnosed with NPM1-mutated AML.

Key Points: 
  • Previously, LANRA demonstrated an acceptable safety profile in clinical trials of more than 250 healthy volunteers and patients with autoimmune diseases.
  • Kronos Bio is developing ENTO for the treatment of patients who are newly diagnosed with NPM1-mutated acute myeloid leukemia (AML) and eligible for intensive induction chemotherapy.
  • Results of a Phase 1b/2 study of entospletinib (GS-9973) monotherapy and in combination with induction chemotherapy in newly diagnosed patients with acute myeloid leukemia.
  • Entospletinib in combination with induction chemotherapy in previously untreated acute myeloid leukemia: response and predictive significance of HOXA9 and MEIS1 expression.

Global Chronic Myeloid Leukemia Markets, Epidemiology and Patient Flow Report 2020-2035 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 12, 2021

b'The "Global Chronic Myeloid Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal Chronic Myeloid Leukemia Epidemiology and Patient Flow Analysis - 2021, provides Chronic Myeloid Leukemia epidemiology, demographics, and patient flow.

Key Points: 
  • b'The "Global Chronic Myeloid Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal Chronic Myeloid Leukemia Epidemiology and Patient Flow Analysis - 2021, provides Chronic Myeloid Leukemia epidemiology, demographics, and patient flow.
  • The data is presented by Pharma G7 countries including the US, France, Spain, Italy, UK, Japan.\nThe research provides population data to characterize Chronic Myeloid Leukemia patients, history of the disease at the population level (Chronic Myeloid Leukemia prevalence, Chronic Myeloid Leukemia incidence) and at the clinical level (from diagnosis to treated patients).
  • It also helps to identify patient sub-groups (age, gender, sub-groups) to understand targeted population for research and development, commercialization.\nChronic Myeloid Leukemia patient flow: Chronic Myeloid Leukemia prevalence, diagnosed, and drug-treated patients\nDemographics: Chronic Myeloid Leukemia patients by age group, gender\nThe data from this research will help executives:\nEstablish basis for Chronic Myeloid Leukemia market sizing, assessing market potential, and developing drug forecast models\nIdentify Chronic Myeloid Leukemia patients segments through age groups, gender, and disease sub-types\nEvaluate Chronic Myeloid Leukemia market opportunities, identify target patient population\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210512005856/en/\n'

Global Acute Myeloid Leukemia Markets, Epidemiology and Patient Flow Report 2020-2035 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, May 12, 2021

b'The "Global Acute Myeloid Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal Acute Myeloid Leukemia Epidemiology and Patient Flow Analysis - 2021, provides Acute Myeloid Leukemia epidemiology, demographics, and patient flow.

Key Points: 
  • b'The "Global Acute Myeloid Leukemia Epidemiology and Patient Flow - 2021" report has been added to ResearchAndMarkets.com\'s offering.\nGlobal Acute Myeloid Leukemia Epidemiology and Patient Flow Analysis - 2021, provides Acute Myeloid Leukemia epidemiology, demographics, and patient flow.
  • The data is presented by Pharma G7 countries including the US, France, Spain, Italy, UK, Japan.\nThe research provides population data to characterize Acute Myeloid Leukemia patients, history of the disease at the population level (Acute Myeloid Leukemia prevalence, Acute Myeloid Leukemia incidence) and at the clinical level (from diagnosis to treated patients).
  • It also helps to identify patient sub-groups (age, gender, sub-groups) to understand targeted population for research and development, commercialization.\nAcute Myeloid Leukemia patient flow: Acute Myeloid Leukemia prevalence, diagnosed, and drug-treated patients\nDemographics: Acute Myeloid Leukemia patients by age group, gender\nThe data from this research will help executives:\nEstablish basis for Acute Myeloid Leukemia market sizing, assessing market potential, and developing drug forecast models\nIdentify Acute Myeloid Leukemia patients segments through age groups, gender, and disease sub-types\nEvaluate Acute Myeloid Leukemia market opportunities, identify target patient population\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210512005835/en/\n'

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos® (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

Retrieved on: 
Tuesday, March 30, 2021

"While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.

Key Points: 
  • "While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.
  • 1The use of Vyxeos for this indication is supported by evidence of effectiveness from study CPX351-301 in adult patients.
  • Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age.
  • Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype.J Clin Oncol.2004 Jun 15;22(12):2510-1.

Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos® (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients

Retrieved on: 
Tuesday, March 30, 2021

"While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.

Key Points: 
  • "While pediatric patients represent a relatively small percentage of total AML patients, there is a critical need for more effective therapies in this setting.
  • 1The use of Vyxeos for this indication is supported by evidence of effectiveness from study CPX351-301 in adult patients.
  • Secondary acute myeloid leukemia has a worse outcome than de novo AML, even taking into account cytogenetics and age.
  • Kern W, Haferlach T, Schnittger S, Hiddemann W, Schoch C. Prognosis in therapy-related acute myeloid leukemia and impact of karyotype.J Clin Oncol.2004 Jun 15;22(12):2510-1.

LYNPARZA® (olaparib) Improved Median Progression-Free Survival to Over Four and a Half Years Compared to 13.8 Months with Placebo for Patients with BRCA-Mutated Advanced Ovarian Cancer

Retrieved on: 
Friday, September 18, 2020

Patients were randomized (2:1) to receive LYNPARZA or placebo for up to two years or until disease progression.

Key Points: 
  • Patients were randomized (2:1) to receive LYNPARZA or placebo for up to two years or until disease progression.
  • Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in
  • The duration of therapy in patients who developed secondary MDS/AML varied from 2 years.
  • Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1).

Positive Phase III Results for Venclexta Combination in Acute Myeloid Leukemia Presented At EHA 2020

Retrieved on: 
Saturday, June 13, 2020

Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia.

Key Points: 
  • Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia.
  • Continued approval for this use may depend on the results of an ongoing study to find out how Venclexta works over a longer period of time.
  • The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS.
  • The patients doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta.

Amphivena Presents Data from First-in-Human Study of AMV564 in Solid Tumor Patients at the ASCO Virtual Annual Meeting 2020

Retrieved on: 
Friday, May 29, 2020

The Phase 1 dose escalation study (NCT04128423) has enrolled 18 advanced solid tumor patients at the time of data cut off.

Key Points: 
  • The Phase 1 dose escalation study (NCT04128423) has enrolled 18 advanced solid tumor patients at the time of data cut off.
  • AMV564 was administered once daily via subcutaneous injection, either alone or in combination with pembrolizumab for 2 weeks out of every 3-week cycle.
  • AMV564 was well tolerated with no dose-limiting toxicities reported in monotherapy or combination therapy cohorts.
  • To date, over 80 patients have received AMV564 across three Phase 1 clinical trials for patients with solid tumors, acute myeloid leukemia (AML), and myelodysplastic syndromes (MDS).

Immune-Onc Therapeutics IND Application for First-In-Human Trial of IO-202, a Novel Antibody for the Treatment of Acute Myeloid Leukemia, Receives FDA Clearance

Retrieved on: 
Friday, May 29, 2020

Acute myeloid leukemia is a devastating disease that needs new approaches and better treatment options.

Key Points: 
  • Acute myeloid leukemia is a devastating disease that needs new approaches and better treatment options.
  • We look forward to working with investigators as we advance the first anti-LILRB4 antibody into the clinic.
  • Despite advances in treatment, less than 30 percent of acute myeloid leukemia patients are alive five years after initial diagnosis.
  • Immune-Oncs lead program IO-202, a first-in-class antibody targeting LILRB4, is being developed to treat acute myeloid leukemia and other cancers.

U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb’s Application for CC-486 for Maintenance Treatment of Adult Patients in Remission with Acute Myeloid Leukemia

Retrieved on: 
Friday, May 1, 2020

The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.

Key Points: 
  • The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.
  • Often, newly diagnosed adult patients with AML achieve a complete response with induction therapy, however many patients will relapse and experience a poor outcome.
  • Patients in remission are seeking treatment options that decrease the likelihood of relapse and extend overall survival, said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb.
  • Acute myeloid leukemia (AML) is the most common type of acute leukemia.