Gilead Halts 6 Zydelig Trials as FDA, EMA Warn of Deaths From Respiratory Infections 

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FDA is alerting health care professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines.

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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.
Philip E. Castle, director of the NCI Division of Cancer Prevention, said he was disappointed to hear that GRAIL’s NHS-Galleri trial did not meet its primary endpoint of reduction in late-stage cancers.

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