Ahmet Dirican: FDA Approves Belzutifan Plus Lenvatinib in Advanced ccRCC
Ahmet Dirican/X

Ahmet Dirican: FDA Approves Belzutifan Plus Lenvatinib in Advanced ccRCC

Ahmet Dirican, Professor of Medical Oncology at Medicana International İzmir Hospital, shared on X:

“A new post-immunotherapy option in advanced ccRCC.

FDA has approved belzutifan + lenvatinib following prior PD-1/PD-L1 therapy, based on the phase III LITESPARK-011 trial.

  • PFS: 14.8 vs 10.7 months; HR 0.70
  • ORR: 52.6% vs 40.2%
  • DoR: 23.0 vs 12.3 months

An important step forward – but with perspective: OS benefit is not yet statistically significant (HR 0.85) and grade ≥3 toxicity remains high (~84%).

A promising new standard after IO, with patient selection and toxicity management remaining crucial.”

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FDA Approved Belzutifan Plus Lenvatinib in Advanced ccRCC

Ahmet Dirican: FDA Approves Belzutifan Plus Lenvatinib in Advanced ccRCC