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Ipsen’s Cabometyx Receives EC’s Approval as a 2L treatment for Radioactive Iodine-Refractory Differentiated Thyroid Cancer

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Ipsen’s Cabometyx Receives EC’s Approval as a 2L treatment for Radioactive Iodine-Refractory Differentiated Thyroid Cancer

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  • The approval was based on the P-III (COSMIC-311) trial evaluating Cabometyx (60mg, qd) vs PBO in a ratio (2:1) in 258 patients with LA or metastatic DTC at 164 sites globally. The trial was sponsored by Exelixis & co-funded by Ipsen
  • The trial had met its 1EPs of PFS & showed a 78% reduction in risk of disease progression or death at a median follow-up of 6.2mos. while other 1EPs showed ORR (15% vs 0%) at a median follow-up of 8.9mos. superior efficacy was maintained
  • The safety profile across 2 analyses was consistent with prior observed for Cabometyx, AEs were managed with dose modifications. The results presented at ESMO 2021 showed superior m-PFS (11.0mos. vs 1.9mos.) at a median follow-up of 10.1mos.

Ref: IPSEN | Image: Businesswire

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Senior Editor

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.

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