Of adaptive and factorial designs A biostatistician’s interpretation of last week’s ODAC

Vinay Prasad regains role as FDA chief medical and scientific officer

Vinay Prasad has regained his role as FDA’s chief medical and scientific officer, according to an update on the agency’s website.

September 12, 2025

Vol.51 No.33

By Claire Marie Porter

Cancer Policy

FDA advances rare disease drug development with new evidence principles

FDA introduced the Rare Disease Evidence Principles to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect.

VCU Massey, MD Anderson researchers awarded $7.3M grant to launch breast cancer clinical trial

Venkata Lokesh BattulaClinton YamA multidisciplinary team of researchers at VCU Massey Comprehensive Cancer Center and MD Anderson Cancer Center has been awarded a $7.3 million grant from the U.S. Department of Defense to fund a novel clinical trial targeting one of the most aggressive and hard-to-treat forms of breast cancer: metastatic triple-negative breast cancer.

September 12, 2025

Vol.51 No.33

In Brief

Seidman Cancer Center to receive additional $3.5M from Kathy Coleman to fund clinical trials

A $3.5 million gift from Kathy Coleman to Because of You: The Campaign for University Hospitals will fuel the future of clinical trials at University Hospitals Seidman Cancer Center.

September 12, 2025

Vol.51 No.33

Clinical Roundup

Rybrevant + Lazcluze block resistance, extend survival in first-line EGFR-mutated NSCLC, phase III trial shows

Rybrevant (amivantamab-vmjw) + Lazcluze (lazertinib) demonstrated a statistically significant and clinically meaningful overall survival improvement for patients with previously untreated locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations, according to data from the phase III Mariposa study.

September 12, 2025

Vol.51 No.33

Clinical Roundup

Tagrisso + chemo demonstrate OS benefit in EGFR-mutated NSCLC, phase III trial shows

Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy in the 1st-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

September 12, 2025

Vol.51 No.33

Of adaptive and factorial designs

A biostatistician’s interpretation of last week’s ODAC

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Vinay Prasad regains role as FDA chief medical and scientific officer

FDA advances rare disease drug development with new evidence principles

VCU Massey, MD Anderson researchers awarded $7.3M grant to launch breast cancer clinical trial

Seidman Cancer Center to receive additional $3.5M from Kathy Coleman to fund clinical trials

Rybrevant + Lazcluze block resistance, extend survival in first-line EGFR-mutated NSCLC, phase III trial shows

Tagrisso + chemo demonstrate OS benefit in EGFR-mutated NSCLC, phase III trial shows

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