FDA grants accelerated approval to Enhertu for HER2-mutant NSCLC and companion diagnostic

After 25 years as FDA’s chief cancer strategist, Richard Pazdur reflects on opportunities for change at the agency

In 1999, Richard Pazdur, a GI oncologist at MD Anderson, saw an FDA recruitment ad in The New England Journal of Medicine. The agency was looking for a director of the FDA Division of Oncology Drug Products.

Rybrevant + Lazcluze show improvement in OS versus osimertinib

Johnson & Johnson announced positive topline results for overall survival from the phase III MARIPOSA study, evaluating Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions (ex19del) or L858R substitution mutations.

January 10, 2025

Vol.51 No.01

Drugs & Targets

FDA approves Ensacove for ALK-positive locally advanced or metastatic NSCLC

FDA approved Ensacove (ensartinib) for adult patients with anaplastic lymphoma kinase-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.

January 10, 2025

Vol.51 No.01

Drugs & Targets

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

FDA cleared an investigational new drug application for a phase I/II clinical trial of REC-4539, a brain penetrant LSD1 inhibitor. Initial clinical investigation will focus on small cell lung cancer while also exploring several other solid tumor indications.

January 10, 2025

Vol.51 No.01

Clinical Roundup

Tecentriq + tiragolumab does not improve OS, updated phase III data finds

Genentech’s phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer, did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.

December 06, 2024

Vol.50 No.45