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FDA expands Gardasil uses, but not users

Executive Summary

Merck's Gardasil vaccine for cervical cancer received approval for prevention of vaginal and vulvar cancer caused by human papilloma virus types 16 and 18, FDA announces Sept. 12. The extended indication still applies to the same age range, women nine to 26. In June, the firm received two "complete response" letters for sBLAs seeking approval for women ages 27 to 45 (1"The Pink Sheet," June 30, 2008, In Brief). Gardasil's label has been revised to note that presently available data is insufficient to support use beyond age 26, and information has been added showing that the vaccine does not protect against diseases caused by HPV types excluded from the vaccine

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Gardasil good for men, too

Merck says it is on track to submit an sBLA by the end of the year for use of its Gardasil human papillomavirus vaccine to prevent external genital lesions caused by HPV types 6, 11, 16 and 18 in men. The firm released a Phase III study Nov. 13 that showed Gardasil prevented 90 percent of external genital lesions caused by those HPV types in men aged 16 to 26. The study also found the vaccine was 85.6 percent effective at reducing persistent infection. Gardasil is approved for preventing HPV-related cancers in women aged nine to 26. Thus far the firm has not been successful in its attempts to expand Gardasil's indication to older women (1"The Pink Sheet," Sept. 15, 2008, In Brief)

Merck’s Gardasil encounters FDA roadblock

Merck received two "complete response" letters to sBLAs for its human papilloma virus vaccine Gardasil for women ages 27 to 45 and for cross-protection, the firm announces June 25. Merck says it will respond to the complete response for older women in July. That application was given priority review in March. However, FDA has indicated data do not support extending the label to include cross-protection. Gardasil was approved in girls and women ages 9 to 26 in 2006 (1"The Pink Sheet," June 12, 2006, p. 3)

QUOTED. 25 February 2021. Adam Saltman.

A recent FDA action plan on artificial intelligence and machine learning (AI/ML) medical software could encourage more to jump in, said Eko Chief Medical Officer Adam Saltman.

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