The Drug Development Letter

Home
Archive
About
Challenges with Reproducibility
My thoughts after a reproducibility paper was retracted.
 • 
Vinay Prasad
2
Lu-PSMA and the need to 'educate' medical professionals about its use.
A dive into the VISION trial, PSMAfore trial, and the questionable practices of the sponsor.
 • 
John-John Schnog
, 
Michael Samson
, and 
Ashley Duits
5
Immune Checkpoint Inhibitors: 10-Year Results in Melanoma Are Now Out – Let's Reflect on These Impressive Advances.
Remarkable advances and remaining questions.
 • 
Timothée Olivier
5
The scattergun approach in research - a deep dive into CDK4/6 inhibitors tested in the neoadjuvant setting.
About forty trials enrolling thousands of patients have been launched since 2010.
 • 
Sahar van Waalwijk
Should US Taxpayers Have Payed For The AMBASSADOR Trial? A poll.
The AMBASSADOR trial has been published in the New England Journal of Medicine, and presented at ESMO 2024.
 • 
Vinay Prasad
5
An Educational Opportunity... ESMO2024 and the LEAP-012 trial!
How a colleague's well-intended comments prompted me to explain several common misunderstandings that should be better taught during oncology training.
 • 
Vinay Prasad
2
Special ESMO 2024 edition !
Timothee Olivier and I discuss the top ESMO 2024 abstracts!
 • 
Vinay Prasad
 and 
Timothée Olivier
36:02
What is a "Seeding Trial"? Tivozanib and the TiNivo-2 trial in renal cancer #ESMO 2024
A thread!
 • 
Vinay Prasad
Driver mutation lung cancer
What is going on?
 • 
Vinay Prasad
1
37:22
Tislelizumab, a novel anti-PD1 in hepatocellular carcinoma? Quality-of-Life, Non-Inferiority, and Duration of Treatment in RATIONALE-301.
Quality-of-life data should be interpreted with extra caution when censoring rates are high.
 • 
Timothée Olivier

August 2024

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.
 • 
Brian Schulte
1
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…
 • 
Vinay Prasad
 and 
Timothée Olivier
7
© 2024 Vinay Prasad
Privacy ∙ Terms ∙ Collection notice
Start WritingGet the app
Substack is the home for great culture