Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. However, ADCs are a nascent therapeutic option and real-world clinical data is emerging daily that is shedding light on the utility and potential of this exciting modality to deliver against its promise.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

Drug Target Review

APRIL 7, 2025

The emergence and adoption of clinically relevant biomarkers is gradually presenting alternatives to MTD, particularly around therapies such as cell and gene therapy (CGT) and immunotherapy. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Rodrigues AD. 113:9861002.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This has spawned a movement focused on optimizing dose selection in oncology drug development.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Progression-free survival (PFS) has been used for accelerated approval, traditional approval, and for measuring direct clinical benefits in certain circumstances. [

FDA 40

FDA Science Clinical Trials Trials 40

Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

FDA 52

FDA Biosimilars Science Production 52