Taletrectinib shrinks tumors in NSCLC indication in phase II trial

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