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FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs

For Immediate Release:
November 23, 2021

 

Today, the U.S. Food and Drug Administration approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication.

Blood and marrow transplants (BMT) help people with advanced myelodysplastic syndromes (MDS)

Not enough people have access to life-saving transplant

Although BMT is the only known cure for MDS, many people aren’t aware of BMT or think that they’re too old to have one because of its side effects. 

Using smaller doses of therapy with BMT have made it safer. Now a new study of 400 older adults, aged 50 to 75, suggests that this type of BMT, along with a matched donor, helps people with advanced MDS live longer with a similar quality of life.

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Hematologic complications of immune checkpoint inhibitors

Immune checkpoint inhibitors are a class of anti-neoplastic therapies that unleash immune cells to kill malignant cells. There are currently 7 medications FDA-approved for the treatment of 14 solid tumors and 2 hematological malignancies. These medications commonly cause immune-related adverse effects due to overactive T lymphocytes, autoantibody production, and/or cytokine dysregulation.

ASTEX PHARMACEUTICALS PRESENTS OVERALL SURVIVAL DATA FROM ASCERTAIN PHASE 3 STUDY OF ORAL HYPOMETHYLATING AGENT INQOVI® (DECITABINE AND CEDAZURIDINE) IN MDS AND CMML AT INTERNATIONAL CONGRESS ON MYELODYSPLASTIC SYNDROMES

Study achieved median overall survival of 31.7 months
Updated efficacy data demonstrated an overall response rate of 62%, with 22% of patients achieving a complete response
INQOVI is the only oral hypomethylating agent with equivalent exposure to its intravenous (IV) form