FDA forces troubled Advaxis to halt enrollment on its PhIII study for lead drug axalimogene
A little more than a month after Amgen quietly walked away from its $65 million upfront to partner with Advaxis $ADXS on axalimogene filolisbac, the biotech is reporting that the FDA has slapped the program with a partial hold ordering a stop to new enrollment in the Phase III. And this isn’t the first time.
According to the company’s release, regulators triggered the hold on their study for cervical cancer due to “requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters.” No new safety issues were identified, according to the biotech.
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