FDA approves imaging drug to help identify lung cancer lesions

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

Neighborhood violence may influence tumor biology, worsening lung cancer outcomes

Scientists have identified a potential driver of aggressive lung cancer tumors in patients who live in areas with high levels of violent crime. Their study found that stress responses differ between those living in neighborhoods with higher and lower levels of violent crime, and between cancerous and healthy tissues in the same individuals.

July 26, 2024

Vol.50 No.30

Clinical Roundup

New payment code and Medicare payment implemented for AI cancer imaging device

Avenda Health, an AI healthcare company, announced the Centers for Medicare & Medicaid Services has assigned a national payment rate for the company’s innovative prostate cancer mapping technology, Unfold AI.

July 26, 2024

Vol.50 No.30

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

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.

July 19, 2024

Vol.50 No.29

By Jacquelyn Cobb

FDA approves imaging drug to help identify lung cancer lesions

YOU MAY BE INTERESTED IN

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

Neighborhood violence may influence tumor biology, worsening lung cancer outcomes

New payment code and Medicare payment implemented for AI cancer imaging device

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.”

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FDA approves imaging drug to help identify lung cancer lesions

YOU MAY BE INTERESTED IN

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

Neighborhood violence may influence tumor biology, worsening lung cancer outcomes

New payment code and Medicare payment implemented for AI cancer imaging device

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.”

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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.”