News and Treatment Updates
Here's where you'll find a regularly updated, broad range of articles written by the AAMDSIF team, allied health organizations and news organizations. By staying well-informed, patients and families are practicing a form of self-support that will help them be more effective self-advocates when engaging with health care providers.
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
Originally Published: 12/22/2021
Article Source: External Web Content
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible...
MDS Update for Q4 2021 - online version
Originally Published: 12/22/2021
Article Source: MDS Update
Please click the link above to find the online version of the MDS Update for Q4 2021.
ASH 2021 Recap: COVID-19 in Patients with Acute Leukemias & Myelodysplasia In Conversation with Dr. Pinkal Desai
Originally Published: 12/21/2021
Article Source: External Web Content
Podcast recording at link above.
ASH 2021 Recap: Multi Omics Sheds New Light on Malignant Transformation from Myeloproliferative Neoplasm to AML
Originally Published: 12/21/2021
Article Source: External Web Content
Link above leads to podcast recording.
Monitoring Amphiregulin May Be Warranted in Caring for Patients with Acute GVHD
Originally Published: 12/19/2021
Article Source: External Web Content
Amphiregulin (AREG) may represent a useful longitudinal monitoring biomarker for patients with life-threatening acute graft-vs-host disease (GVHD), according to a sample of 2 prospective clinical trials that was presented at the 2021 ASH Annual Meeting. Specifically, patients with a high baseline of AREG are at an increased mortality risk and, therefore, should be monitored consistently during serial assessments.
Specifically, in a multivariate analysis for survival, day 28 responses (risk ratio [RR], 9.14; P <.0001) and baseline AREG (>212 pg/mL; RR, 2.72; P <.05) were the only...
Women With AML Have Worse Outcomes With Gemtuzumab Ozogamicin
Originally Published: 12/17/2021
Article Source: External Web Content
Combination gemtuzumab ozogamicin (GO) and cytarabine is no more effective than standard chemotherapy for older adults with previously untreated, standard-risk acute myeloid leukemia (AML), a phase 2/3 trial suggests.
In fact, GO plus cytarabine was associated with worse event-free survival (EFS) in women.
These findings were presented at the 2021 American Society of Hematology (ASH) Annual Meeting by Juliette Lambert, MD, PhD, of Versailles Hospital in France.
(Article continues at link.)
Aspaveli® (pegcetacoplan) approved in EU as orphan drug for treatment of PNH
Originally Published: 12/15/2021
Article Source: External Web Content
Published: Dec 15, 2021
STOCKHOLM, Dec. 15, 2021 /PRNewswire/ --
The first targeted C3 therapy approved in the EU
Approval based on results from head-to-head PEGASUS phase 3 study where Aspaveli demonstrated superiority to eculizumab in improving haemoglobin levels1
Aspaveli will have market exclusivity for paroxysmal nocturnal haemoglobinuria (PNH) based on orphan drug designation
Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Apellis Pharmaceuticals Inc (Nasdaq: APLS) announced today that the European Commission (EC) has approved Aspaveli® (pegcetacoplan), the first and...
FDA Approves First Drug to Prevent Graft Versus Host Disease
Originally Published: 12/15/2021
Article Source: External Web Content
Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD), a condition that occurs when donor bone marrow or stem cells attack the graft recipient, in combination with certain immunosuppressants. Orencia may be used in adults and pediatric patients two years of age or older undergoing hematopoietic stem cell transplantation (commonly known as bone marrow transplantation or stem cell transplantation) from an unrelated donor.
This is the first FDA drug approval for aGVHD prevention and incorporates...
Certain Patients With Myelodysplastic Syndromes, Acute Leukemia at Higher Risk of Severe COVID-19 Illness
Originally Published: 12/14/2021
Article Source: External Web Content
Myelodysplastic syndromes (MDS) and neutropenia were both found to be strong, independent predictors of severe COVID-19 illness in patients with acute leukemia or MDS who developed COVID-19, according to data from the American Society of Hematology (ASH) RC COVID-19 Registry for Hematology presented at the ASH Annual Meeting and Exposition 2021. However, active disease alone for hospitalized patients was not associated with greater odds of dying from COVID-19, nor was receiving ongoing cancer treatment, according to the study.
The analysis included data from 135 patients with acute myeloid...
Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
Originally Published: 12/08/2021
Article Source: External Web Content
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).
The product is only authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2. The authorization also requires that...