Gardasil gets CHMP nod for vaginal lesions

The European indication for US drug major Merck & Co's cervical cancer vaccine Gardasil is likely to be extended to include prevention of precancerous vaginal lesions. The four-strain vaccine received a positive opinion from the European Medicines Agency (EMEA) for an extension of its marketing authorization to include the prevention of this condition.

The EMEA's Committee for Medicinal Products for Human Use (CHMP) recommended that the prevention of precancerous vaginal lesions due to HPV types 16 and 18 be added to the licensed indications for Gardasil. These two strains cause about 58% of HPV-related vaginal cancer. The European Commission could now approve the extended marketing authorization within weeks, Merck noted.

"Precancerous vaginal lesions are difficult to detect. The treatment to avoid progression to cancer is challenging and often requires ablative therapy, partial vaginectomy and radiotherapy in the case of invasive cancer. Recurrence is common," said Elmar Joura, professor of gyneco-oncology at the University of Vienna, Austria. "In addition, women may suffer from anxiety, depression, sexual dysfunction and poor self-image, resulting in broken lives," he added.