Archive - The Drug Development Letter

FDA "agnostic" approvals in rare cancers: highlighted by trastuzumab deruxtecan – targeting HER2 – in patients with sarcoma

It’s my pleasure to introduce this guest commentary by my UCSF colleague Brian Schulte.

Aug 30 •

Why Should a Top FDA Official Unilaterally Approve an Expensive Gene Therapy? The Case of Elevidys.

Peter Marks, the director of the Center for Biologics Evaluation and Research within the Food and Drug Administration (FDA), unilaterally approved…

Aug 1 •

and

Timothée Olivier

July 2024

Response Rate Tricks in Oncology: RAS inhibitors on the spot again...

Response Rate is a measure of anti-cancer drug activity. It's more reliable in early phase trials than PFS estimates ... yet to be analyzed with great…

Jul 19 •

and

Timothée Olivier

Project Orbis — harmonizing up or down?

By Kristina Jenei

Jul 12

Eli Lilly's Court Victory: Dutch Agency Must Reevaluate Abemaciclib Amid Controversy

Eli Lilly’s court appeal to override the negative assessment of abemaciclib in the Netherlands

Jul 7 •

Sahar van Waalwijk

CDK4/6 inhibitors as adjuvant therapy in early breast cancer? Uncertain benefits, guaranteed harms

This is the title of our new paper out in the European Journal of Cancer!

Jul 2 •

,

, and

Timothée Olivier

June 2024

Are Patient Advocacy Groups Free from Industry Influence?

Find the results of our new paper in the Journal of Cancer Policy.

Jun 30 •

John-John Schnog

THEOREMM - A Novel Framework for Cancer Registration Trials

"Trials in HEmatology and Oncology REviewed by Metaresearch Methods"

Jun 27 •

and

Timothée Olivier

Should the LAURA trial change our practice, and how? A PRO-CON debate!

Maintenance osimertinib in unresectable stage III EGFR-mutant cancer.

Jun 26 •

and

Timothée Olivier

Postrecurrence treatment in neo/adjuvant trials.

Is it better to treat all patients early on, or to spare those who are already cured and only treat those who relapse?

Jun 20 •

Timothée Olivier

EDITOR'S PICK: Overdiagnosis and Overtreatment in Melanoma.

A paper advocating against routine skin screening "for all".

Jun 18 •

and

Timothée Olivier

Special post for our French-speaking followers!

How to interpret oncology randomized clinical trials... in french!

Jun 12 •

Timothée Olivier

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