Millennium Files sNDA for Velcade for Mantle Cell NHL

Millennium Pharmaceuticals announced it has filed a supplemental new drug application (sNDA) with the U.S. FDA for Velcade (Bortezomib) in the treatment of relapsed or refractory mantle cell lymphoma (MCL), anaggressive subtype of non-Hodgkin's lymphoma (NHL). The filing is based on final data from the Phase II trial, one of the largest multi-center studies in relapsed MCL to date, which showed a 33 percent overall response rate and an eight percent complete response rate. Importantly, the median duration of response was 9.2 months; 13.5 months in patients achieving a complete response. These results are similar to four other Phase II clinical trials that recorded overall response rates of 30 to 40 percent with single-agent Velcade.



Deborah Dunsire, M.D., President and CEO, Millennium says "The results from multiple Phase II mantle cell studies are part of our larger NHL program that includes an ongoing Phase III follicular lymphoma trial. The sNDA filing also represents another step forward to expand the role of Velcade in order to meet the needs of patients with a variety of cancers."



Currently, Velcade has been approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. To date, over 33,000 multiple myeloma patients have been treated with Velcade worldwide. Earlier this year, Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C., initiated a Phase III clinical trial with Velcade in combination with rituximab(Rituxan/MabThera)in patients with relapsed or refractory follicular lymphoma. News Release

Blog Category: 

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...

Radiation Therapy Topics

...

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...

Sitemap