FDA accepts Telix’s NDA for prostate cancer imaging agent

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.

July 26, 2024

Vol.50 No.30

By Jacquelyn Cobb and Paul Goldberg

Clinical Roundup

Novel liquid biopsy methodology can track evolution of metastatic prostate cancer

DNA/RNA material contained in circulating extracellular vesicles secreted into the bloodstream by tumor cells captures cancer genomics and transcriptomic evolution in patients with metastatic prostate cancer, according to a new study.

July 26, 2024

Vol.50 No.30

Drugs & Targets

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.

July 26, 2024

Vol.50 No.30

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.

Nubeqa + androgen deprivation therapy improves rPFS for mHSPC in phase III trial

The phase III ARANOTE trial, investigating Nubeqa (darolutamide) plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer, has met its primary endpoint of radiological progression-free survival. Nubeqa plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.

July 19, 2024

Vol.50 No.29

Clinical Roundup

Living in disadvantaged neighborhoods influences stress-related genes, which may contribute to aggressive prostate cancer in African American men

Those living in disadvantaged neighborhoods have significantly higher activity of stress-related genes, research suggests, which could contribute to higher rates of aggressive prostate cancer in African American men.

July 19, 2024

Vol.50 No.29

FDA accepts Telix’s NDA for prostate cancer imaging agent

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

Novel liquid biopsy methodology can track evolution of metastatic prostate cancer

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Nubeqa + androgen deprivation therapy improves rPFS for mHSPC in phase III trial

Living in disadvantaged neighborhoods influences stress-related genes, which may contribute to aggressive prostate cancer in African American men

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FDA accepts Telix’s NDA for prostate cancer imaging agent

YOU MAY BE INTERESTED IN

ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications

Novel liquid biopsy methodology can track evolution of metastatic prostate cancer

FDA clears IND for Zymeworks’ antibody drug conjugate ZW191

Platinum drugs are off the shortage list, but the underlying problem is unsolvedFDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”

Nubeqa + androgen deprivation therapy improves rPFS for mHSPC in phase III trial

Living in disadvantaged neighborhoods influences stress-related genes, which may contribute to aggressive prostate cancer in African American men

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Platinum drugs are off the shortage list, but the underlying problem is unsolved
FDA’s Califf: “We have a market failure due to unwillingness of health systems and cancer centers to pay a fair price.”