FDA approves Vidaza in newly diagnosed JMML

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

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

Conversation with The Cancer Letter

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

The Supreme Court struck down the Chevron doctrine, removing one of the foundational principles of administrative law and upending the way federal agencies rely on technical subject-matter expertise. What comes next?

July 05, 2024

Vol.50 No.27

By Matthew Bin Han Ong

Conversation with The Cancer Letter Regulatory News

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC
Pooled analysis finds correlations between early endpoints and OS in ICI trials

When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.

March 15, 2024

Vol.50 No.11

By Matthew Bin Han Ong and Paul Goldberg

Clinical

First-ever commercial TIL therapy: How NCI, Iovance, and Moffitt achieved FDA approval

In a major breakthrough in cellular therapy, FDA has approved the first tumor-infiltrating lymphocyte therapy for patients with unresectable or metastatic melanoma who have received prior treatment, including with checkpoint inhibitors.

February 23, 2024

Vol.50 No.08

By Matthew Bin Han Ong

Conversation with The Cancer Letter

Steven Rosenberg, Friedrich Graf Finckenstein: FDA recognition of TIL therapy is the result of 40 years of research

Feb. 16, 2024, is a landmark date in the history of immuno-oncology.

February 23, 2024

Vol.50 No.08

By Matthew Bin Han Ong

FDA approves Vidaza in newly diagnosed JMML

YOU MAY BE INTERESTED IN

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

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

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC
Pooled analysis finds correlations between early endpoints and OS in ICI trials

First-ever commercial TIL therapy: How NCI, Iovance, and Moffitt achieved FDA approval

Steven Rosenberg, Friedrich Graf Finckenstein: FDA recognition of TIL therapy is the result of 40 years of research

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FDA approves Vidaza in newly diagnosed JMML

YOU MAY BE INTERESTED IN

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

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

Georgetown’s Zachary Baron on the post-Chevron era: We need guardrails about when agency expertise should be cast aside

FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLCPooled analysis finds correlations between early endpoints and OS in ICI trials

First-ever commercial TIL therapy: How NCI, Iovance, and Moffitt achieved FDA approval

Steven Rosenberg, Friedrich Graf Finckenstein: FDA recognition of TIL therapy is the result of 40 years of research

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FDA’s Harpreet Singh: Overall survival data tells the full story of immune checkpoint inhibitor benefit in NSCLC
Pooled analysis finds correlations between early endpoints and OS in ICI trials