BridgeBio, BMS to develop and commercialize SHP2 inhibitor BBP-398

Ipsen and Sutro Biopharma form global licensing deal for an ADC targeting solid tumors

Ipsen and Sutro Biopharma formed an exclusive global licensing agreement for STRO-003, an antibody-drug conjugate in the final stages of preclinical development which targets the ROR1 tumor antigen which is known to be overexpressed in many different cancer types including solid tumors and hematological malignancies.

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.

March 29, 2024

Vol.50 No.13

By Paul Goldberg

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

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

BridgeBio, BMS to develop and commercialize SHP2 inhibitor BBP-398

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Ipsen and Sutro Biopharma form global licensing deal for an ADC targeting solid tumors

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

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

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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BridgeBio, BMS to develop and commercialize SHP2 inhibitor BBP-398

YOU MAY BE INTERESTED IN

Ipsen and Sutro Biopharma form global licensing deal for an ADC targeting solid tumors

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

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

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