FDA grants marketing authorization to Parsortix System for liquid biopsy in MBC

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

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

Drugs & Targets

FDA accepts Telix’s NDA for prostate cancer imaging agent

FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.

July 26, 2024

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

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.

Electronic prompt for surgeons may reduce breast cancer overtreatment

University of Pittsburgh and UPMC Hillman Cancer Center researchers have developed a novel prompt, or ‘nudge,’ embedded in the electronic health record that flags, for treating surgeons, older patients with early-stage breast cancer who may be at risk for unnecessary lymph node surgery.

July 19, 2024

Vol.50 No.29

FDA grants marketing authorization to Parsortix System for liquid biopsy in MBC

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 accepts Telix’s NDA for prostate cancer imaging agent

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.”

Electronic prompt for surgeons may reduce breast cancer overtreatment

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FDA grants marketing authorization to Parsortix System for liquid biopsy in MBC

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 accepts Telix’s NDA for prostate cancer imaging agent

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.”

Electronic prompt for surgeons may reduce breast cancer overtreatment

Login

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.”