Daniel Michaeli: Key takeaways from our new article on breast cancer drugs

Daniel Michaeli shared a post on LinkedIn, about a recently published paper:

Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price.

Authors: Julia Caroline Michaeli, Thomas Michaeli, Dario Trapani, Sebastian Albers, Dominik Dannehl, Rachel Würstlein, Daniel Tobias Michaeli.

”Excited to share our new article ‘Breast cancer drugs: FDA approval, development time, efficacy, clinical benefits, innovation, trials, endpoints, quality of life, value, and price’ with Dario Trapani, D. Dannehl, R. Würstlein – here the key takeaways:

• We examined 26 drugs with 42 indications for breast cancer from 2000 to 2023.
• The median development time was 7.8 years.
• Only 26% of treatments were considered innovative. 64% were small molecules, 19% antibodies, and 18% antibody-drug conjugates.
• Clinical trials supporting FDA approval were predominantly phase 3 trials (88%) of randomized controlled design (66%), enrolling a median of 585 patients at 181 centers across 19 countries.
• New drugs improved OS by a median of 2.8 months and PFS by 4.4 months. In single-arm trials, the average ORR was 31%.
• Although 60% of new treatments were considered ‘high-value’ (ESMO-MCBS), only 14% demonstrated improvements in quality of life.
• The median price was $16,000 per month. There was no association between prices and patient benefit. The median value per life year gained was $62,500.”

Source: Daniel Michaeli/LinkedIn

Daniel Michaeli is a Medical Doctor at the National Center for Tumor Diseases (NCT) in Heidelberg and at Ruprecht-Karls University Heidelberg. His research focuses on drug development, clinical trials, and healthcare policy.