FDA clears IND application for Recursion’s LSD1 inhibitor REC-4539

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.

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

NeXT Personal MRD test predicts NSCLC outcomes, phase III trial shows

NeXT Personal, a highly sensitive molecular residual disease test, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer receiving neoadjuvant therapy, according to data from NeoADAURA phase III clinical trial run by AstraZeneca.

September 12, 2025

Vol.51 No.33

Drugs & Targets

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA has approved gemcitabine intravesical system (Inlexzo) for adults with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors. Gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.

September 12, 2025

Vol.51 No.33

Drugs & Targets

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

FDA granted Breakthrough Therapy designation to Hernexeos (zongertinib tablets) for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations.

September 12, 2025

Vol.51 No.33

FDA clears IND application for Recursion’s LSD1 inhibitor REC-4539

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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

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

NeXT Personal MRD test predicts NSCLC outcomes, phase III trial shows

FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer

FDA grants Hernexeo Breakthrough Therapy designation as first line use for HER2-mutant advanced NSCLC

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