ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

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

Drugs & Targets

FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

FDA granted approval for Lyrfigtu (lirafugratinib) as a treatment option for patients with cholangiocarcinoma with FGFR2 fusion or other rearrangement.

September 25, 2026

Vol.52 No.35

ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

YOU MAY BE INTERESTED IN

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

FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

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ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

YOU MAY BE INTERESTED IN

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

FDA approves Lyrfigtu for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma

Never miss an issue!

Login

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