Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
On 5/19/09,
Biogen (
NASDAQ:BIIB) and
Genentech (acquired by Roche) (
OTC:RHHBY) announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL). The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months for an estimated PDUFA decision date of 11/19/09. The applications are based on positive results from two of the largest global Phase 3 clinical trials conducted in patients with CLL, which showed that Rituxan plus standard chemotherapy for CLL extended the time patients lived without the cancer advancing (progression-free survival or PFS) compared to those receiving chemotherapy alone.
In CLL8, previously untreated patients who received Rituxan plus chemotherapy had a 69% improvement in PFS (41 percent risk reduction, hazard ratio=0.59; p<0.0001; 95% confidence interval: 0.44,0.72) compared to those who received chemotherapy alone. In REACH, patients whose cancer relapsed after previous treatment had a 54% improvement in PFS after receiving Rituxan plus chemotherapy compared to patients receiving chemotherapy alone (35 percent risk reduction, hazard ratio=0.65; p=0.0002; 95% confidence interval: 0.51, 0.82).
Salix Pharma (NASDAQ:SLXP): A U.S. advisory panel on Tuesday rejected a Debiovision Inc drug to treat a dangerous type of bleeding in the esophagus. The FDA advisory committee voted 14-0 that current data did not show that the benefits of the drug, Sanvar (vapreotide), outweighed potential risks. SLXP is the U.S. marketing partner for Swiss-based Debiopharm, which filed its complete response to the FDA on 11/4/08 in response to an earlier approvable letter for Sanvar.
