FDA issues Complete Response Letter to Eisai for Dacogen sNDA

Astex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter to partner Eisai for their supplemental New Drug Application (sNDA) for Dacogen (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction [...]

CML patients can benefit from imatinib after unsuccessful interferon therapies

A new study has found that patients with chronic myeloid leukemia (CML) who have not responded to interferon treatments experience long-term benefits when they switch to the targeted drug imatinib.

FDA, pharmaceutical companies announce solution to cancer drug shortage

The U.S. Food and Drug Administration and several pharmaceutical companies said Tuesday they have reached agreements to alleviate shortages for the drugs methotrexate and Doxil. Methotrexate is used to treat children with a form of leukemia and others with tumors of the breast and lungs. Doxil is used to treat ovarian cancer and multiple myeloma.

ASH addresses severe shortage of methotrexate drug

As the world’s largest professional society concerned with the causes and treatment of blood disorders, many of ASH’s more than 16,000 members are on the front lines of dealing with the country’s severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia.

Supply of childhood leukemia drug nearly exhausted

A medicine to treat children’s leukemia is in such short supply that hospitals may run out within weeks; meanwhile, families of people with Alzheimer’s disease are clamoring to use a skin-cancer drug after a promising study in mice.

Childhood Leukemia Drug, Methotrexate, In Short Supply

Methotrexate, a drug used to treat acute lymphoblastic leukemia, the most common childhood leukemia, is now also in short supply in the USA, along with several other lifesaving drugs. According to the FDA, vital lifesaving hospital drugs have not been so scarce in ten years. Methotrexate works by slowing down the rate at which cancer [...]

Panel Nixes AML Indication for Dacogen

WASHINGTON (MedPage Today) — An FDA advisory committee voted 10-3, with one abstention, against expanding the indication for decitabine (Dacogen) for use in elderly acute myelogenous leukemia (AML) patients.

FDA Staff Says Decitabine No Help in AML

WASHINGTON (MedPage Today) — Decitabine (Dacogen), a hypomethylating agent, does not appear to improve mortality in older patients with acute myelogenous leukemia, FDA reviewers concluded.

EUSA Pharma acquires ASPAREC development and commercialization rights

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that it has acquired the exclusive worldwide development and commercialization rights to ASPAREC for the treatment of acute lymphoblastic leukemia (ALL) from Alizé Pharma.

Chemotherapy drugs can lead to relapse of leukemia

The chemotherapy drugs required to push a common form of adult leukemia into remission may contribute to DNA damage that can lead to a relapse of the disease in some patients, findings of a new study suggest.