FDA approves imaging drug to help identify lung cancer lesions

The Galleri MCD vote: What FDA asked its advisors to ignore

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval.

September 30, 2026

News Analysis Regulatory News

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee voted in favor of Galleri to become the first multi-cancer detection test to receive regulatory approval.

September 25, 2026

Vol.52 No.35

By Jacquelyn Cobb and Sara Willa Ernst

Perspective

When did stage 3B lung cancer become “early stage”?

My recent column about Merck’s television commercial for perioperative Keytruda left me with a question I could not shake.

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

Heidi Overton, President Trump’s nominee for FDA Commissioner, defended the agency’s recent policy decisions reversing its hardball stance on flavored nicotine products, as she appeared in front of the Senate Committee on Health, Education, Labor, and Pensions on Sept 24.

HHS issues direct final rule to reduce reliance on animal testing

FDA has issued a direct final rule that changes the language in its regulations so that “animal testing” is no longer described as the default or defining form of “nonclinical” safety testing.

September 25, 2026

Vol.52 No.35

By Claire Marie Porter

Clinical Roundup

Tagrisso increased OS in early-stage EGFR-mutated lung cancer at eight year follow-up, ADAURA phase III trial finds

Tagrisso (osimertinib) demonstrated a sustained, clinically meaningful overall survival benefit at eight years compared to placebo in the adjuvant treatment of patients with early-stage (1B, 2, and 3A) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent, according to the updated exploratory results from the ADAURA phase III trial.

September 25, 2026

Vol.52 No.35

FDA approves imaging drug to help identify lung cancer lesions

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says

When did stage 3B lung cancer become “early stage”?

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

HHS issues direct final rule to reduce reliance on animal testing

Tagrisso increased OS in early-stage EGFR-mutated lung cancer at eight year follow-up, ADAURA phase III trial finds

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FDA approves imaging drug to help identify lung cancer lesions

YOU MAY BE INTERESTED IN

The Galleri MCD vote: What FDA asked its advisors to ignore

FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claimsClinical benefit will not be considered for approval, FDA says

When did stage 3B lung cancer become “early stage”?

At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

HHS issues direct final rule to reduce reliance on animal testing

Tagrisso increased OS in early-stage EGFR-mutated lung cancer at eight year follow-up, ADAURA phase III trial finds

Never miss an issue!

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FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims
Clinical benefit will not be considered for approval, FDA says