Below is a summary of updates to the
BioMedReports.com FDA Calendar, which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of
BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.
On 6/8/09, Micromet (NASDAQ:MITI) announced the presentation of Phase 2 clinical data of the BiTE® antibody blinatumomab (MT103), which showed a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease. Blinatumomab is a novel therapeutic antibody that activates a patient's T cells to seek out and destroy cancer cells. The patients included in this Phase 2 study were in complete hematological remission following intense chemotherapy regimens, but retained a detectable level of ALL cancer cells in their bone marrow -- so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD. Currently, 13 of 16 (81% of evaluated patients) have shown an MRD response, thus qualifying the trial as having met its primary endpoint before the completion of the study and MITI will discuss a pivotal ALL program with regulatory authorities later in the year.
On 6/8/09, Keryx Biopharma (NASDAQ:KERX) announced results of its Phase 2 study of Zerenex (ferric citrate) for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on thrice weekly hemodialysis. The top line efficacy and safety results from this Phase 2 study were submitted to the FDA, and discussed at a recent face to face meeting with the Division of Cardiovascular and Renal Drug Products. The FDA also reviewed the final reports for the 90-day rat and 16-week canine toxicology studies. The FDA indicated that the results of the Phase 2 study and the toxicology studies were adequate to support entry into a Phase 3 program.
