Merck KGaA got the green light from the FDA to restart its late-stage lung cancer program for its therapeutic vaccine Stimuvax, which had been halted after a patient in a multiple myeloma trial contracted encephalitis in March.
Licensed from Oncothyreon, the German pharma company has made a committed effort to bring in a trove of late-stage data on a range of cancers for its closely-watched therapeutic vaccine. Investigators now have an approval to ramp the lung cancer trials back up while leaving the breast cancer trial on hold for now.
"Merck KGaA worked constructively with the FDA and other health authorities to address the questions raised on the safety of BLP25 liposome vaccine in patients with NSCLC and, as a result, we can now resume our NSCLC clinical program," commented Dr. Bernhard Kirschbaum, head of Global Research and Development. "We have meanwhile received a number of regulatory approvals to restart in other countries and await approval in the remaining countries."
"This is another set of good news from the pharma division that had had some mishaps in recent months," noted DZ Bank AG analyst Elmar Kraus. In an embarrassing setback, the German pharma company was recently forced to resubmit its application for the MS drug cladribine after regulators refused to accept the app as presented.
- check out Merck KGaA's release
- here's the story from Bloomberg