Merck obtains second FDA complete response letter for cancer drug

The agency has completed its review of the response that Merck provided in July 2008 and has recommended that Merck submit additional data when the 48 month study has been completed. The initial supplemental biologics license application (sBLA) included data collected through an average of 24 months from enrollment into the study, which is when the number of pre-specified endpoints had been met.

Following a review of the final results of the study, Merck anticipates providing a response to the agency in the fourth quarter of 2009. The letter does not affect current indications for Gardasil in females ages nine through 26 nor does the letter relate to the sBLA that was submitted in December 2008 for the use of Gardasil in males.

Gardasil is currently indicated for use in girls and young women nine through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by human papillomavirus (HPV) types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.