Merck’s Gardasil Receives FDA Nod For Expanded Cancer Indications

Merck (MRK) has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for its Gardasil 9 vaccine for the prevention of oropharyngeal and other head and neck cancers.

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These cancers are caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial that is now underway, says Merck.

Both men and women can be at risk for HPV-attributable oropharyngeal cancer; however, this cancer affects men five times more than women. For most people, HPV clears on its own. But, for those who don’t clear the virus, it can cause certain cancers.

According to a recent model published by the U.S. Centers for Disease Control and Prevention, HPV-attributable oropharyngeal cancer has surpassed cervical cancer as the most prevalent type of HPV-related cancer in the U.S.

“At Merck, working to help prevent certain HPV-related cancers has been a priority for more than two decades,” said Dr. Alain Luxembourg of Merck Research Laboratories. “Today’s approval for the prevention of HPV-related oropharyngeal and other head and neck cancers represents an important step in Merck’s mission to help reduce the number of men and women affected by certain HPV-related cancers.”

The vaccine is already approved in females 9-45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and in men age 9-45 for the prevention of anal, oropharyngeal and other head and neck cancers caused by the same HPV Types. For both men and woman it is approved for lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

Overall, analysts have a bullish outlook on Merck stock with a Strong Buy consensus. This is made up of 9 recent buy ratings vs 3 hold ratings. The average analyst price target stands at $92 (21% upside potential). (See Merck stock analysis on TipRanks)

However, Wolfe Research analyst Tim Anderson recently downgraded Merck to hold from buy noting that while Merck is still a “good company,” its stock looks increasingly “stuck.” Indeed, shares are now down 16% year-to-date, and flat on a three-month basis.