FDA grants Merck sBLA priority review for Keytruda + chemoradiotherapy in cervical cancer

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

Perspective

Oncology has a semantics problem: How do we define “early stage”?

I recently found myself asking a question that I thought had an obvious answer: What is early-stage cancer?

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 grants Merck sBLA priority review for Keytruda + chemoradiotherapy in cervical cancer

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

Oncology has a semantics problem: How do we define “early stage”?

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 grants Merck sBLA priority review for Keytruda + chemoradiotherapy in cervical cancer

YOU MAY BE INTERESTED IN

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

Oncology has a semantics problem: How do we define “early stage”?

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

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?”