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FDA to scrutinize unproven cancer drugs after 10-year gap

https://medicalxpress.com/news/2021-04-fda-scrutinize-unproven-cancer-drugs.html

Excerpt:

Each year the U.S. approves dozens of new uses for cancer drugs based on early signs that they can shrink or slow the spread of tumors.

But how often do those initial results translate into longer, healthier lives for patients?

That seemingly simple question is one of the thorniest debates in medicine. It spills into public view Tuesday as the Food and Drug Administration convenes the first meeting in a decade to consider clawing back approvals from several cancer drugs that have failed to show they extend or improve life.

The agency says it has used innovative research shortcuts to speed up the availability of medicines for desperately ill patients. But many researchers say it has failed to crack down on medications that don’t deliver on their early promise, leaving a glut of expensive, unproven cancer drugs on the market.

...In 1992, Congress gave the FDA the ability to accelerate drug approvals based on preliminary study data, responding to protests from HIV patients and activists over the slow pace of drug development. The program was embraced by the industry for giving many drugs a faster, cheaper path to market.

As originally conceived, these quicker approvals functioned like a contract: If the drugs weren’t shown to help patients live longer or better lives in follow-up studies, the approvals would be revoked.

... The FDA has used its authority to revoke an accelerated cancer approval only once. That long, ugly experience still looms large over the agency’s oversight of cancer drugs.

It took the FDA more than a year to finally pull the breast cancer approval from Roche’s blockbuster drug Avastin. The agency was besieged by calls from cancer patients and libertarian groups to keep the approval, despite clear evidence that it didn’t extend life and caused dangerous side effects.

The drugs under review this week—Merck’s Keytruda, Roche’s Tecentriq and Bristol Myers Squibb’s Opdivo—are part of a recent wave of “immunotherapies” that help the body’s defense system recognize and attack cancer. The blockbuster drugs have shown life-extending gains against deadly forms of skin and lung cancer, among other conditions. But they’ve also racked up several dozen approvals in other indications, including forms of bladder, throat and liver cancer that are the focus of the meeting.

Studies by all three companies have shown negative or inconclusive results.

Accelerated approval is technically reserved for drugs that fill an “unmet need.” But today roughly a third of all cancer drugs reach the market through the pathway, including many drugs approved for overlapping uses.

In a 2018 study, FDA staffers deemed the program a success, noting only 5% of accelerated cancer approvals had ever been withdrawn and 55% had been “verified” by follow-up studies.

But when Harvard researchers dug into that claim, they found that only about 20% of cancer drugs had actually been shown to extend lives. In most cases, the FDA had allowed drugmakers to confirm their drugs’ worth by conducting a second study of a preliminary measure, such as tumor shrinkage or delayed tumor growth.

In some cancers, shrinking or slowing tumor growth is proven to benefit patients. But in many cases that link hasn’t been established.

“Having a smaller cancer that kills you, rather than a bigger cancer, is no consolation because you’re still dead,” said Emanuel.

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If the FDA is this way towards cancer drugs just imagine how they will be towards “Covid” drugs. No thank you.