Regulation

Swayed by lack of alternatives, ODAC votes to retain Tecentriq accelerated approval for triple-negative breast cancer

Given the drug’s lack of confirmatory data in the indication, the outcome could lower confidence in the accelerated approval pathway.

Given lack of confirmatory data, the outcome could lower confidence in accelerated approval pathway

ODAC asks FDA to retain Tecentriq, Keytruda accelerated approvals for bladder cancer  

Committee swayed by clinical experience and lack of alternatives over failure of postmarket trials to verify benefit.

Next up: panel weighs Keytruda, Opdivo for second-line liver cancer 

ODAC heeds Pazdur, recommends pulling Keytruda as third-line gastric cancer therapy

In hepatocellular carcinoma, ODAC votes favor Keytruda but not Opdivo.

In hepatocellular carcinoma, ODAC votes favor Keytruda but not Opdivo

Will FDA change the accelerated approval paradigm for cancer?

ODAC meeting poses challenges for FDA


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<h1 class="text title" doc-editable="text" data-component-id="doc-1ef7l320d0">Swayed by lack of alternatives, ODAC votes to retain Tecentriq accelerated approval for triple-negative breast cancer</h1><h2 class="title-bottom webtitle" doc-editable="title" data-component-id="doc-1ef7l34r60">Given lack of confirmatory data, the outcome could lower confidence in accelerated approval pathway</h2><div class="byline ng-tns-c17-4 ng-star-inserted" data-component-id="doc-1ef7l3fol0">
    <span class="ng-tns-c17-4" doc-editable="text">By Steve Usdin, Washington Editor</span>
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

Roche

U.S. Food and Drug Administration (FDA)

The lack of substantially better alternative therapies, rather than compelling clinical data, seems to have prompted an FDA advisory committee to vote 7-2 ...