FDA widens use of cancer drug Merck acquired for $1B

Dive Brief:

• The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
• Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
• Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.

Dive Insight:

Welireg is a new kind of cancer drug, blocking production of a protein called HIF-2 alpha that is implicated in cancer growth. Merck believes the treatment could become a blockbuster medicine and future growth driver, though it has a long way to go, generating about $146 million in sales through the first nine months of 2023. 

That number could rise substantially with its new approval in kidney cancer, a larger market opportunity than the rare condition for which it was first approved. The FDA has specifically cleared Welireg for use in kidney cancer patients after they’ve received an immunotherapy, like Merck’s Keytruda, and a type of targeted medicine. 

The approval was granted quickly, only months after Merck in August reported positive interim results from a pivotal trial. Yet there are questions about the benefits Welireg provides. At a medical meeting in October, Merck revealed that, while Welireg’s response rates and effects on cancer progression had widened, it hasn’t provided a survival benefit. That finding has led some oncologists to question its value.

Its impact on cancer’s march has also been modest, with study results showing it helped patients live a median of 5.6 months before their disease got worse or death, comparable to everolimus. The 25% relative risk reduction measured for Welireg over everolimus is the result of delayed progression in patients who surpassed the 5.6-month median, according to the drug’s prescribing information.

Still, the drug will fill a gap, as it’s the first specifically approved for its particular patient group. It’s also provided a blueprint for others in development. Arcus Biosciences has a similar drug in testing against advanced tumors, including kidney cancers. 

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