Ipsen’s Cabometyx Receives CHMP's Recommendation for Approval in the EU to Treat Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Shots:
- The recommendation was based on the P-III (COSMIC-311) trial evaluates Cabometyx (60mg, qd) vs PBO in a ratio (2:1) in 258 patients with LA or metastatic DTC at 164 sites globally
- In an interim analysis with a median follow-up of 6.2mos, 78% reduction in risk of disease progression or death, ORR (15% vs 0%) at a median follow-up of 8.9mos., m-PFS (11.0mos. vs 1.9mos.) & maintained a reduction in risk of disease progression or death of 78% with a median follow-up of 10.1mos. The safety profiles were consistent with previously observed for Cabometyx
- Cabometyx is approved in the US for RCC, HCC, RAI-R DTC & for advanced RCC as a 1L treatment. The therapy is also approved in the EU & other regions globally for RCC
Ref: Ipsen | Image: Ipsen
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
