Photo from Daniel Michaeli/LinkedIn
Oct 1, 2024, 08:28
Daniel Michaeli: Key takeaways from our new article on breast cancer drugs
Daniel Michaeli shared a post on LinkedIn, about a recently published paper:
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.
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