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

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath

When Marsha B. Henderson, former FDA Associate Commissioner of Women’s Health (1998-2019), sat down for an oral history interview upon her retirement from the agency, she could not have foreseen becoming party to a government digital purge 7 years later. Over the past week, the Trump administration has been busy at work deleting government webpages...

FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

FDA granted orphan drug designation to MB-105, March Biosciences’s first-in-class CD5-targeted CAR T-cell therapy, for the treatment of relapsed/refractory CD5-positive T-cell lymphoma.

February 07, 2025

Vol.51 No.05

White House

Tracking Trump’s early impact on cancer policy
Research and care disrupted, NCI programs face unpredictable future

The Trump administration did exactly what it said it would do to disorient anyone involved in making policy or touched by it. The president and his crew have “flooded the zone”—the term and the image are theirs, as is the strategy of dropping a flurry of executive orders and memoranda that shake the foundations of the American system of government, raising questions of legality and constitutionality, and, above all, making it a challenge for anyone to see the entire picture and think strategically.

Dual-targeted therapies + chemo shows high response rates in BRAF-mutated metastatic CRC, phase III trial shows

Patients with metastatic colorectal cancer harboring BRAF V600E mutations benefitted from first-line treatment with the targeted therapies Braftovi(encorafenib) and Erbitux(cetuximab) plus a mFOLFOX6 chemotherapy regimen, according to results from the phase III BREAKWATER trial led by researchers at the University of Texas MD Anderson Cancer Center.

January 31, 2025

Vol.51 No.04

Drugs & Targets

FDA approves Enhertu as first HER2-directed therapy for breast cancer

FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

January 31, 2025

Vol.51 No.04

Drugs & Targets

FDA approves Grafapex as preparative regiment for allogeneic hematopoietic stem cell transplantation in AML or MDS

FDA approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome on Jan. 22.

January 31, 2025

Vol.51 No.04

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

YOU MAY BE INTERESTED IN

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath

FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

Tracking Trump’s early impact on cancer policy
Research and care disrupted, NCI programs face unpredictable future

Dual-targeted therapies + chemo shows high response rates in BRAF-mutated metastatic CRC, phase III trial shows

FDA approves Enhertu as first HER2-directed therapy for breast cancer

FDA approves Grafapex as preparative regiment for allogeneic hematopoietic stem cell transplantation in AML or MDS

Renew today!

Subscriber content

Never miss an issue!

Login

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

YOU MAY BE INTERESTED IN

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”Preserving an oral history by the former FDA associate commissioner of women’s heath

FDA grants orphan drug designation to MB-105 for CD5-targeted CAR T-cell therapy

Tracking Trump’s early impact on cancer policyResearch and care disrupted, NCI programs face unpredictable future

Dual-targeted therapies + chemo shows high response rates in BRAF-mutated metastatic CRC, phase III trial shows

FDA approves Enhertu as first HER2-directed therapy for breast cancer

FDA approves Grafapex as preparative regiment for allogeneic hematopoietic stem cell transplantation in AML or MDS

Never miss an issue!

Login

Marsha Henderson: “You have to continue to push for what you think is the right thing for public health.”
Preserving an oral history by the former FDA associate commissioner of women’s heath

Tracking Trump’s early impact on cancer policy
Research and care disrupted, NCI programs face unpredictable future