FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

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.

January 10, 2025

Vol.51 No.01

By Paul Goldberg

Clinical Trials & Tribulations

New colorectal cancer screening strategies must advance the standard of care

Colorectal cancer is the second leading cause of cancer-related death in the United States. Accurate and early detection of CRC and precancerous lesions is critical for reducing incidence and preventing deaths from this disease.

Ibrance + standard-of-care extends median PFS by over 15 months in HR+, HER2+ metastatic breast cancer, phase III trial shows

The phase III PATINA trial demonstrated that the addition of Ibrance (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival by investigator assessment in patients with hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer.

January 10, 2025

Vol.51 No.01

Drugs & Targets

FDA issues draft guidance on including tissue biopsies in clinical trials

FDA issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical trials.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

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

YOU MAY BE INTERESTED IN

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

New colorectal cancer screening strategies must advance the standard of care

Ibrance + standard-of-care extends median PFS by over 15 months in HR+, HER2+ metastatic breast cancer, phase III trial shows

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

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