European committee recommends pixantrone be granted conditional approval
Claiming the medication satisfies an unmet medical need, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Cell Therapeutics' (CTI) oncology product Pixuvri (pixantrone) be granted conditional approval for the treatment of B-cell non-Hodgkin’s lymphoma in patients with aggressive disease that has relapsed or recurred after "multiple rounds of previous chemotherapy or is not responding to other treatments."
Conditional approval was granted, and not full approval, as the committee believed the data supplied by CTI displays a medical benefit that outweigh the risks but is not yet comprehensive, and that more information will be required on the benefits.
This is a surprising accomplishment for CTI in Europe, but it will not sway the US FDA's negative opinion on pixantrone and the data supporting it.
Source: EMA
More Articles
More Articles
Amazon.com is pleased to have the Lymphoma Information Network in the family of Amazon.com associates. We've agreed to ship items...
The question ought to be what are myelodysplastic syndromes (MDS), since this is a group of similar blood and bone marrow diseases that...
Merkel Cell Carcinoma (MCC) is a very rare and aggressive skin cancer that usually develops when a person is in his or her 70s. It is...
At some point, the Seattle biotech company Cell Therapeutics Inc (CTI) should earn an entry in the Guinness Book of World Records for utter and...
Site Beginnings
This site was started as Lymphoma Resource Page(s) in 1994. The site was designed to collect lymphoma...
Three papers appearing in the journal Blood and pointing towards a regulator-suppressor pill could offer hope to blood cancer...
The US Food and Drug Administration (FDA) has granted a third so-called Breakthrough Therapy Designation for the investigational oral...
The US Food and Drug Administration today has approved an expanded use of Imbruvica (ibrutinib) in patients with...
The U.S. Food and Drug Administration has announced that it has granted "Breakthrough Therapy Designation" for the investigational agent...
According to a new study published in the Proceedings of the National Academy of Sciences, a team from the University of California, San...
Pharmacyclics has announced that the company has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for...
New research suggests that frontline radioimmunotherapy...
Gilead Sciences has announced results of the company's Phase II study of its investigational compound idelalisib, an oral inhibitor of...
