Merck’s Keytruda has a new indication, and with it, immunotherapy has moved into a new frontier.
With a Tuesday FDA green light for certain previously treated cervical cancer patients whose disease has worsened on or after chemotherapy, Keytruda became the first drug in its class to win a nod to treat those with the disease.
Regulators gave their stamp of approval after 14.3% of recurrent or metastatic cervical cancer sufferers with tumors testing positive for the PD-L1 biomarker showed responses to the drug at a study’s 11.7-month mark. That response lasted six months or longer in 91% of patients, a showing that earned Keytruda the FDA’s “priority review” tag.
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The new go-ahead gives Merck an opportunity to rack up cervical cancer sales before its rivals can. Merck is competing against Bristol-Myers Squibb, Roche, AstraZeneca and a further-behind Merck KGaA-Pfizer team in the PD-1/PD-L1 arena, and it's facing down one or more of those companies in many of its markets, including melanoma, bladder cancer and lung cancer.
Still, the pharma giant is doing its best to ensure that people don’t develop the disease in the first place. It markets Gardasil 9, a vaccine that prevents the cervical cancer-causing human papillomavirus (HPV).
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Right now, Gardasil bears an OK for women and men age nine to 26, but Merck is in the process of changing that. Tuesday, U.S. regulators granted a priority review to the New Jersey company's bid to extend the approval through age 45 in both females and males.
In the first quarter, revenue for Merck’s Gardasil franchise grew 24%, trouncing analyst expectations, but the boost was largely thanks to a launch in China. In the U.S., Gardasil sales fell after a CDC-endorsed switch to a two-dose regimen rather than a three-dose regimen.