ADXS-HER2: FDA hold

Advaxis said FDA placed a clinical hold on ADXS-HER2 and ADXS-PSA. The move follows a clinical hold placed on the company’s axalimogene filolisbac in early October in response to a safety report concerning the death of a patient who tested positive for L. monocytogenes more than 2 years after her last treatment in an investigator-led trial of the therapy (see BioCentury, Oct. 19). FDA agreed with investigators assessment that the patient’s cause of death was the result of cervical cancer progression but placed holds on ADXS-HER2 and ADXS-PSA so the agency’s evaluation could be simultaneously applied to all products. The company does not expect a “significant interruption” to its clinical programs. ...