Cullinan Oncology, Taiho Pharmaceuticals complete agreement to develop and commercialize CLN-081/TAS6417

Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

Non-classical mutations are present in 20-30% of all patients with epidermal growth factor receptor-mutated non-small cell lung cancer, according to an analysis of real-world evidence presented by Black Diamond Therapeutics, Inc. at the American Association of Cancer Research annual meeting.

April 12, 2024

Vol.50 No.15

Drugs & Targets

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.

Observational study demonstrates clinical validity and utility of OncoHost’s PROphet NSCLC test

A mutli-center observational study demonstrated the clinical validity and utility of the PROphet non-small cell lung cancer test, a plasma proteome machine learning-based decision-support tool designed to identify patient subsets benefiting from PD-1/PD-L1 inhibitor-based therapies.

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

Cullinan Oncology, Taiho Pharmaceuticals complete agreement to develop and commercialize CLN-081/TAS6417

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Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

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

Observational study demonstrates clinical validity and utility of OncoHost’s PROphet NSCLC test

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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Cullinan Oncology, Taiho Pharmaceuticals complete agreement to develop and commercialize CLN-081/TAS6417

YOU MAY BE INTERESTED IN

Non-classical mutations present in 20-30% of all patients with EGFR-mutated NSCLC, analysis shows

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

Observational study demonstrates clinical validity and utility of OncoHost’s PROphet NSCLC test

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

Login

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