Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

The U.S. Department of Health and Human Services announced that it is making sweeping revisions by cutting personnel, centralizing functions, and consolidating divisions.

March 28, 2025

Vol.51 No.12

By Claire Marie Porter and Jacquelyn Cobb

In Brief

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Paradigm Health announced on March 20 the appointment of Karen E. Knudsen to its board of directors, alongside the upcoming launch of its eSource clinical trial data application.

March 28, 2025

Vol.51 No.12

Clinical Roundup

Investigational Orca-T treatment for hematologic malignancies meets primary endpoint in phase III trial

Orca Bio, a late-stage biotechnology company, on March 17 announced results from the pivotal phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukemia. Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

March 28, 2025

Vol.51 No.12

Drugs & Targets

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approved cabozantinib (Cabometyx) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors and well-differentiated extra-pancreatic neuroendocrine tumors.

March 28, 2025

Vol.51 No.12

Drugs & Targets

FDA approves prostate cancer imaging agent Gozellix

FDA approved Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), a next-generation PSMA-PET imaging agent for prostate cancer.

March 28, 2025

Vol.51 No.12

Clinical Roundup

Elahere shows survival benefit in long-term analysis for ovarian cancer patients in phase III study

AbbVie announced the final analysis of the confirmatory phase III MIRASOL trial evaluating the efficacy and safety of Elahere in women with folate receptor alpha-positive platinum-resistant ovarian cancer compared to chemotherapy.

March 21, 2025

Vol.51 No.11

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

YOU MAY BE INTERESTED IN

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Investigational Orca-T treatment for hematologic malignancies meets primary endpoint in phase III trial

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

Elahere shows survival benefit in long-term analysis for ovarian cancer patients in phase III study

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Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

YOU MAY BE INTERESTED IN

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hitAlso this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology

Karen Knudsen joins Paradigm Health’s board of directors as company prepares launch of AI-driven clinical trial data collection and management application

Investigational Orca-T treatment for hematologic malignancies meets primary endpoint in phase III trial

FDA approves cabozantinib for patients 12 and up with pNET and epNET

FDA approves prostate cancer imaging agent Gozellix

Elahere shows survival benefit in long-term analysis for ovarian cancer patients in phase III study

Kennedy announces massive cuts, centralization at HHS—NCI and FDA hit
Also this week: Columbia yields, Makary and Bhattacharya confirmed, tariffs on pharmaceuticals, and more changes impacting oncology