Biovest seeking market approval for lymphoma vaccine in Canada

Biovest International, the maker of the as-yet-unapproved BiovaxID, a personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, is announcing that it will pursue market approval for the vaccine in Canada as early as this year.

Biovest intends to file a New Drug Submission (NDS) later in 2012 with Health Canada, that country's drug approval agency. If approved by Health Canada, BiovaxID would represent the world’s first cancer vaccine available for lymphoma.

Biovest made the decision to pursue approval after meeting with Health Canada's Biologics and Genetic Therapies Directorate (BGTD). In that meeting, Biovest presented the results of three separate clinical trials conducted over a decade in conjunction with the United States' National Cancer Institute. Two trials were Phase II and the third, a controlled, randomized, double-blinded, multi-center Phase III clinical trial.

Said Carlos F. Santos, Ph.D., Biovest’s Senior Vice President of Product Development & Regulatory Affairs:

"Our meeting with Canada’s BGTD confirms the comprehensive and robust nature of our clinical data including data from three long-running clinical trials ... our studies provide a substantial body of evidence of vaccine safety and efficacy, including the first randomized vaccine trial to show benefit in lymphoma and demonstrate that BiovaxID provides patients with an effective and highly-safe vaccination option to complement current treatment options."

Source: Biovest

More Articles

More Articles

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...

In a large trial of older, newly diagnosed patients with chronic lymphocytic leukemia (CLL),...

Today’s typical treatments have been unable to cure numerous types of lymphoma, but emerging immunotherapies could provide the key to...

Biotech firm Gilead Sciences Inc. has announced that the first patient has been dosed in a Phase III trial evaluating the safety and efficacy of...

Last week at the 54th American Society of Hematology Annual Meeting and Exposition in Atlanta, researchers out of MD Anderson Cancer Center in...

The results of a pair of long-term survival studies indicate the therapeutic value of BEXXAR (...

A new lab test that can improve survival rates among patients with chronic lymphocytic leukemia (...

Aggressive Non-Hodgkin’s Lymphomas (NHLs) are fast growing cancers (as opposed to indolent cancers). They involve...

A B cell is a type of lymphocyte that produces antibodies to fight infections. These are the most prevalent lymphocytes in the bloodstream and are...

Sitemap