FDA releases draft guidance aimed at improving oncology clinical trials for accelerated approval

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

Clinical Roundup

PDS0101 + pembrolizumab in HPV16+ R/M head and neck cancer show anti-tumor activity, VERSATILE-002 phase II study finds

PDS0101 plus pembrolizumab showed antitumor activity in ICI-naive HPV16-positive R/M HNSCC, according to the results of a phase II trial.

September 25, 2026

Vol.52 No.35

FDA releases draft guidance aimed at improving oncology clinical trials for accelerated approval

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

PDS0101 + pembrolizumab in HPV16+ R/M head and neck cancer show anti-tumor activity, VERSATILE-002 phase II study finds

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FDA releases draft guidance aimed at improving oncology clinical trials for accelerated approval

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

PDS0101 + pembrolizumab in HPV16+ R/M head and neck cancer show anti-tumor activity, VERSATILE-002 phase II study finds

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