The Chinese State Food and Drug Administration recently approved an oncolytic adenovirus for use in combination with chemotherapy in the treatment of late-stage refractory nasopharyngeal cancer. It is the first gene therapy to be granted approval by a regulatory agency.
H101 is a recombinant human Type 5 adenovirus in which the E1B-55kDs gene has been deleted, enabling it to selectively replicate in and lyse p53-mutated tumor cells while leaving normal cells unaffected. It is administered via intratumoral injection.
The approval was based on data from a multicenter, randomized, Phase III clinical trial, showing that the addition of H101 therapy yielded a 27 percent increase in overall response rates (complete or partial) compared with fluorouracil plus cisplatin-based chemotherapy alone.