seeking accelerated approval from FDA; intends to apply for approval in Europe, Asia, and Australia 10/08; positive data presented as ASCO 6/09; FDA grants orphan drug designation (2/10); BLA expected to be filed in 2010 (4/10); company announced it is targeting mantle cell lymphoma, in addition to follicular lymphoma, as a next indication (6/10)
Brand BiovaxID Generic autologous lymphoma-derived idiotype-specific vaccination
Company name Biovest Product type Speciality
Therapeutic category Antineoplastics Key uses Non-Hodgkin's Lymphoma (NHL)
Other Uses mantle cell lymphoma, follicular lymphoma Drug Class autologous tumor derived immunoglobulin idiotype vaccine
Dosage From SC Expected Approval 2010-Q4
FDA Filing N/A Last Update date June 29,2010
Link to news release
Link to published data
Link to clinicaltrials.gov
Link to press releases