What NHS-Galleri taught us—and what it didn’t

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

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

Clinical Roundup

COA survey finds high bispecific therapy adoption among community oncology practices

The Community Oncology Alliance announced results from a national survey examining how independent community oncology practices deliver bispecific therapies on Sept. 22.

September 25, 2026

Vol.52 No.35

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

Congress settled the FY26 question in February, with NCI receiving $7.352 billion, an increase of $128 million over the prior year. After a year in which cancer center directors spent an extraordinary share of their leadership attention defending the research enterprise, that outcome deserves to be called what it was: a win.

OST-HER2-treated patients show statistically significant benefit in interim three-year OS analysis of phase IIb pulmonary metastatic osteosarcoma trial

OST-HER2-treated patients showed statistically significant benefit in an interim three-year overall survival data analysis when compared with a combined published historical control arm being used for regulatory interactions. The analysis is from the company’s phase IIb trial for the prevention or delay of recurrence in patients with fully resected, pulmonary metastatic osteosarcoma (the “Metastatic Osteosarcoma Program”).

September 18, 2026

Vol.52 No.34

What NHS-Galleri taught us—and what it didn’t

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

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

COA survey finds high bispecific therapy adoption among community oncology practices

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

OST-HER2-treated patients show statistically significant benefit in interim three-year OS analysis of phase IIb pulmonary metastatic osteosarcoma trial

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What NHS-Galleri taught us—and what it didn’t

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

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

COA survey finds high bispecific therapy adoption among community oncology practices

The end of “more money, more people, more trials”Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.

OST-HER2-treated patients show statistically significant benefit in interim three-year OS analysis of phase IIb pulmonary metastatic osteosarcoma trial

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

The end of “more money, more people, more trials”
Cancer centers are being asked to grow their portfolios on flat budgets. Headcount is the wrong answer.