Zhaohui Su, VP of Biostatistics at Ontada, shared a post on LinkedIn about a recent article by Allan Cramer et al, published in British Journal of Clinical Pharmacology:
“A study by Allan Cramer and colleagues shows that EMA and FDA make highly aligned oncology drug approval decisions (>90% agreement).
Key findings include:
- Over 90% agreement in final approval decisions for both new cancer drugs and extensions of indication.
- FDA decisions are quicker, with a median of 216 days for new drugs compared to 424 days at the EMA, and 176 days versus 295 days for extensions.
- The majority of applications are extensions, indicating that oncology innovation often builds on existing therapies.
- The times between submission and decision do not meaningfully influence the final decision.”
Title: Cancer drug applications to the EMA and the FDA: A comparison of new drugs and extension of indication in terms of approval decisions and time in review
Authors: Allan Cramer, Freja Karuna Hemmingsen Sørup, Hanne Rolighed Christensen, Tonny Studsgaard Petersen, Kristian Karstoft
Read the Full Article on British Journal of Clinical Pharmacology
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