FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.

October 14, 2026

NCI Regulatory News

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

As the debate around Galleri, the multi-cancer detection test developed by GRAIL Inc., rages on, fueled most recently by the full-steam-ahead support it has received from regulatory and legislative bodies, NCI Director Anthony Letai has turned his attention to the available data.

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

FDA approved Tuksya (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tuksya to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

October 09, 2026

Vol.52 No.37

Regulatory News

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.

October 02, 2026

Vol.52 No.36

By Claire Marie Porter

Clinical Regulatory News

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

For the past four decades, psilocybin research has focused on one area: the treatment of mental health disorders, including depression, anxiety, existential distress associated with serious medical illnesses, post-traumatic stress disorder, and addiction.

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approved Degevma (denosumab-adet) as a biosimilar to Xgeva (denosumab).

October 02, 2026

Vol.52 No.36

FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

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As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

FDA approves Degevma, a biosimilar for cancer-related bone complications

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FDA advisory committee to vote on GRAIL’s multi-cancer detection test, Galleri

YOU MAY BE INTERESTED IN

As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

FDA approves Degevma, a biosimilar for cancer-related bone complications

Never miss an issue!

Login

Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use
“Projecting sub-ideal tests across a large population can cause harm,” Letai says, as Galleri cruises toward FDA approval

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”