ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

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

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.

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

FDA granted Fast Track designation for Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.xxx:more

July 12, 2024

Vol.50 No.28

Judiciary News Analysis

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

YOU MAY BE INTERESTED IN

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

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.”

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

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ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

YOU MAY BE INTERESTED IN

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

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.”

FDA grants Fast Track designation to 225Ac-FL-020 radiopharmaceutical for mCRPC

Supreme Court removes “Chevron deference,” threatening drug regulation, health coverage, delivery of cancer care

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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.”