FDA’s Activism Changes the Landscape In Treatment, Trials of Squamous NSCLC

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Citing a dramatic improvement in overall survival in second-line squamous non-small cell lung cancer, FDA rapidly approved the Bristol-Myers Squibb drug Opdivo (nivolumab).

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Paul Goldberg
Editor & Publisher

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On Feb. 19, GRAIL Inc. announced that its pivotal NHS-Galleri trial failed to meet its primary endpoint of reduction in advanced stage cancers. The media and the market reacted as one would expect: GRAIL’s stock price halved the day after the announcement and at least three law firms said that they are conducting investigations in preparation for filing investor suits.
If you listen to GRAIL executives discuss the results of the long-awaited trial of the company’s multicancer detection test, you might be led to conclude that the company’s pivotal NHS-Galleri study had an overwhelmingly positive result.
Undeterred by the negative topline result of its pivotal trial of Galleri, a multicancer detection test, the test’s sponsor, GRAIL, said it’s forging ahead with its plan to get FDA approval and reimbursement from CMS and private insurers.
Paul Goldberg
Editor & Publisher

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