ONCOLYTIC GENE THERAPY APPROVED FOR HEAD AND NECK CANCER IN CHINA

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.