EMA grants PRIME designation to DNX-2401

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Amid deepening controversy, Vinay Prasad, FDA’s top clinician and scientist, and director of its Center for Biologics Evaluation and Research, will be leaving the agency.

March 13, 2026

By Claire Marie Porter

Regulatory News

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

March 13, 2026

By Jacquelyn Cobb

Podcast

One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome

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.

March 11, 2026

News Analysis

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study
Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

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.

March 06, 2026

Vol.52 No.09

By Jacquelyn Cobb and Sara Willa Ernst

Conversation with The Cancer Letter

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

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.

March 06, 2026

Vol.52 No.09

By Jacquelyn Cobb and Sara Willa Ernst

Conversation with The Cancer Letter

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

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.

March 06, 2026

Vol.52 No.09

By Jacquelyn Cobb and Sara Willa Ernst

EMA grants PRIME designation to DNX-2401

YOU MAY BE INTERESTED IN

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study
Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

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EMA grants PRIME designation to DNX-2401

YOU MAY BE INTERESTED IN

Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again)

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

One result, two reactions: GRAIL’s Hall and NCI’s Castle react to negative NHS-Galleri trial outcome

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal studyWhere GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs

Never miss an issue!

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Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

GRAIL presses on with Galleri test despite missed primary endpoint in pivotal study
Where GRAIL sees signals of benefit in the subgroups, screening experts see signs of overdiagnosis

GRAIL’s Megan Hall: “I think we can be confident that there is clinical benefit to implementing this technology. And I think that’s really hard to argue with.”
Mainstream epidemiologists beg to differ

NCI’s Philip Castle on NHS-Galleri results: “I’m sorry that it didn’t work, but it keeps the national conversation going.”
Castle is “disappointed” by Galleri results but not discouraged by implications for MCDs