FDA Rejects ITM-11 Radiopharmaceutical, Stalling Rival to Novartis Therapy
TL;DR Summary
The FDA rejected ITM-11, ITM Isotope Technologies Munich’s radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors, due to manufacturing issues, halting a potential rival to Novartis’ therapy; early ITM data suggested ITM-11 could extend progression-free survival (23.9 months vs 14.1 months with everolimus).
Topics:business#biotech#fda#gep-nets#itm-isotope-technologies-munich#manufacturing-issues#radiopharmaceuticals
- In surprise decision, FDA rejects radiopharma therapy expected to rival Novartis treatment STAT
- ITM cancer drug spurned by FDA over manufacturing qualms Fierce Pharma
- ITM Says FDA Issues Complete Response Letter For 177Lu-Edotreotide (ITM-11) NDA TradingView
- ITM Receives Complete Response Letter for ¹⁷⁷Lu-edotreotide (ITM-11) WBOC TV
Reading Insights
Total Reads
1
Unique Readers
4
Time Saved
2 min
vs 3 min read
Condensed
91%
440 → 40 words
Want the full story? Read the original article
Read on STAT