FDA granted orphan drug designation to ADXS-HPV for the treatment of stage II-IV invasive cervical cancer.
ADXS-HPV is an immunotherapy drug candidate, developed by Advaxis Inc., which is designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues.
ADXS-HPV is designed to infect antigen-presenting cells and direct them to generate a powerful, cellular immune response to HPV E7. The resulting cytotoxic T cells infiltrate and attack the tumors while specifically inhibiting tumor Tregs and MDSCs in the tumors that are protecting it, according to the drug’s sponsor.
Orphan drug designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the U.S. The designation entitles the sponsor to clinical protocol assistance with the FDA, as well as annual grant funding, tax credits, waiver of PDUFA filing fees, and potentially a seven-year market exclusivity period.
The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Gardasil to be used for the prevention of anal precancerous lesions and anal cancers, causally related to oncogenic HPV types 16 and 18.
This new indication is supported by the results of a study showing the high efficacy of Gardasil against anal precancerous lesions linked to HPV types 6, 11, 16 & 18 (AIN 2/3) which are recognized as immediate precursors of anal cancers. A CHMP positive opinion is one of the final steps before a variation to the marketing authorization granted by the European Commission.
Gardasil is currently licensed from the age of nine years, for the prevention of premalignant genital lesions (cervical, vulvar and vaginal) and cervical cancer causally related to certain oncogenic HPV types and genital warts causally related to specific HPV types.
Gardasil, manufactured by Merck, is a quadrivalent vaccine for protection against cancer of the cervix and other genital diseases caused by the human papillomavirus types 6, 11, 16 and 18: precancerous lesions of the cervix (CIN2/3), precancerous lesions of the vulva (VIN2/3) and vaginal (VaIN2/3) and genital warts.
