Volume 22 Issue 2, February 2023

The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016.

The discovery of the monoclonal antibody trastuzumab almost 25 years ago revolutionized treatment and drug development for HER2⁺ breast cancer. Here, Swain et al. review the current standard of care for HER2⁺ breast cancer, describe mechanisms of drug resistance and focus on next-generation platforms and therapies for the treatment of this disease.

Tumour suppressor gene TP53 is frequently mutated in cancer, and therapeutic strategies to restore the functionality of p53 in tumours have been pursued for decades without success. This Review discusses the promising approaches towards p53-based therapy that have emerged in recent years.

Studies of human genetics have been used to identify promising drug targets, and might also inform safety assessment in the drug discovery process. In their Review, Ward and co-authors from industry discuss how genetic studies of rare and complex human diseases can be used to predict potential on- and off-target effects associated with modulating a given target. They also outline suggested best practices for incorporating human genetic data into safety assessments during drug development.