Velcade Approved for Mantle Cell Lymphoma in Europe
The European Commission approved the drug Velcade (bortezomib) for the treatment of adults with previously untreated mantle cell lymphoma (MCL).
Velcade had previously only been approved for the treatment of multiple myeloma.
This latest indication is specifically for use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CAP, or VR-CAP when Velcade is included) in treatment-naive patients who are deemed unsuitable for a blood stem cell transplantation.
Previous trial led to drug's approval
Approval was based on data from LYM-3002, a random and controlled Phase III trial that included 487 patients diagnosed with mantle cell lymphoma who were not eligible for a transplantation. The trial pitted VR-CAP against R-CHOP.
"We are delighted that the European Commission has approved extending the indications for use of Velcade to include first-line therapy for patients with mantle cell lymphoma," said Thomas Stark, Janssen EMEA Vice President of Medical Affairs. "We already offer Imbruvica as a second-line treatment in MCL and are pleased to be able to provide additional treatment options for this disease to patients and physicians."
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...
