NEJM Evidence publishes positive results from pivotal bladder cancer clinical trial

COTA and Sanofi collaborate to accelerate cancer trials using real-world data and AI

COTA, a leader in real-world data and analytics for oncology, is entering a collaboration with Sanofi to use RWD and artificial intelligence to increase the speed of oncology trials, including for multiple myeloma.

April 19, 2024

Vol.50 No.16

Clinical Roundup

One in five people with cancer participate in medical research studies, Fred Hutchinson study shows

Researchers from Fred Hutchinson Cancer Center, the American Cancer Society Cancer Action Network, and peer institutions released findings in the Journal of Clinical Oncology showing that when all types of cancer research studies are considered, at least one in five people with cancer, or 21.9%, participate in some form of clinical research.

April 05, 2024

Vol.50 No.14

Regulatory News

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

FDA issued Complete Response Letters for the Biologics License Application for odronextamab in relapsed/refractory follicular lymphoma and in R/R diffuse large B-cell lymphoma, each after two or more lines of systemic therapy.

Etta Pisano named senior portfolio lead at ARPA-H

Etta D. Pisano was named senior portfolio lead at the Advanced Research Projects Agency for Health.

March 29, 2024

Vol.50 No.13

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

Guest Editorial

How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

The clinical development strategy in oncology during the last decade has been substantially affected in several ways by the advent of immunotherapy, and more recently, cell and gene therapy treatment options. xxx:more

March 15, 2024

Vol.50 No.11

By Tanja Obradovic

NEJM Evidence publishes positive results from pivotal bladder cancer clinical trial

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Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

Etta Pisano named senior portfolio lead at ARPA-H

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

How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

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NEJM Evidence publishes positive results from pivotal bladder cancer clinical trial

YOU MAY BE INTERESTED IN

COTA and Sanofi collaborate to accelerate cancer trials using real-world data and AI

One in five people with cancer participate in medical research studies, Fred Hutchinson study shows

Exercising new powers, FDA issues Complete Response Letters based on insufficient enrollment in confirmatory trials

Etta Pisano named senior portfolio lead at ARPA-H

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

How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

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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