New colorectal cancer screening strategies must advance the standard of care

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.

FDA issues draft guidance on including tissue biopsies in clinical trials

FDA issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.

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 approves Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

FDA approved Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1).

January 10, 2025

Vol.51 No.01

Drugs & Targets

FDA approves Unloxcyt for metastatic or locally advanced cutaneous squamous cell carcinoma

FDA approved Unloxcyt (osibelimab-ipdl), a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

January 10, 2025

Vol.51 No.01

Drugs & Targets

FDA approves Ryoncil for steroid-refractory acute graft versus host disease in pediatric patients

FDA approved Ryoncil (remestemcel-L-rknd), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients two months of age and older. Ryoncil is the first FDA-approved MSC therapy.

January 10, 2025

Vol.51 No.01

New colorectal cancer screening strategies must advance the standard of care

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

FDA issues draft guidance on including tissue biopsies in clinical trials

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

FDA approves Tevimbra + chemo for first-line treatment of gastric and GEJ cancers

FDA approves Unloxcyt for metastatic or locally advanced cutaneous squamous cell carcinoma

FDA approves Ryoncil for steroid-refractory acute graft versus host disease in pediatric patients

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