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

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:

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.

Breast Cancer cancer cancer drugs Cancer research cancer treatment cancer trial Daniel Michaeli Dario Trapani Dominik Dannehl ESMO FDA Julia Caroline Michaeli OncoDaily Oncology Rachel Würstlein Sebastian Albers Thomas Michaeli

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