The drugs under review have been approved for multiple indications, and they have demonstrated improved survival for some cancers, including non-small-cell lung cancer and melanoma. ![]() ![]() Tumors with high PD-L1 expression tend to respond better to this kind of treatment-but not always.Ĭheckpoint inhibitors are highly effective against some types of cancer, particularly so-called “hot” tumors that attract immune cells. Medications that block the interaction between PD-1 and PD-L1, its binding partner on tumor cells, can restore T-cell activity. PD-1 is a checkpoint receptor on T cells that regulates immune function some tumors can hijack PD-1 to turn off immune responses. These drugs are all PD-1 or PD-L1 checkpoint inhibitors, monoclonal antibodies that help the immune system fight cancer. “However, when confirmatory trials do not confirm clinical benefit, a reevaluation must be performed to determine if the approval should be withdrawn.”Īlthough the therapies under consideration-Keytruda, Opdivo and Tecentriq (atezolizumab)-have not shown the expected clinical benefits in confirmatory trials, the advisory panel recommended keeping four provisional approvals in place while two others failed to make the grade.Īs part of an industry-wide evaluation, four other accelerated approvals were recently voluntarily withdrawn by their companies in consultation with the FDA: Opdivo and Keytruda for previously treated metastatic small cell lung cancer, and Tecentriq and Imfinzi (durvalumab) for locally advanced or metastatic bladder cancer. “We are committed to ensuring the integrity of the accelerated approval program, which is designed to bring safe and effective drugs to patients with unmet medical needs as quickly as possible,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement. This is the first such meeting since 2011. Drug company representatives made their case for continued approval, and patient advocates had a chance to weigh in. At a public meeting of the FDA’s Oncology Drugs Advisory Committee (ODAC), held April 27 to 29, an expert panel reviewed six checkpoint inhibitor accelerated approvals to determine whether they should remain in effect. Richard Schilsky April 26, 2021īut this appears to be changing. The FDA has revoked an accelerated approval of a cancer drug only once-Avastin (bevacizumab) for breast cancer-because its benefits did not outweigh its risks.Īccelerated approval requires post-market studies to demonstrate clinical benefit. Critics argue that this has left expensive drugs without proven clinical benefit on the market. Some drug companies fail to carry out further studies, some do not report follow-up results promptly and the FDA has not taken action in a timely manner. ![]() However, this process has not been very efficient. The FDA can rescind approval if treatments don’t continue to measure up, or accelerated approval can be upgraded to traditional full approval if they do. ![]() Medications that are granted accelerated approval are still required to undergo further testing to confirm that they do in fact provide clinical benefits such as improved survival with longer follow-up. “A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit,” according to the FDA. Rather than waiting until enough clinical trial participants have died to determine whether a drug offers a survival advantage, medications may be approved faster based on surrogate endpoints-for example, HIV viral load for AIDS medications or tumor shrinkage for cancer drugs. Under pressure from AIDS activists and other patient advocates, the FDA created an accelerated approval program in the early 1990s to allow earlier approval of therapies that treat serious conditions and address unmet medical needs. A Food and Drug Administration (FDA) advisory panel recommended last week that four “dangling” accelerated approvals of checkpoint inhibitors should remain in effect while two others-Opdivo (nivolumab) for liver cancer and Keytruda (pembrolizumab) for stomach cancer-should be withdrawn.
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