TKI - September 2020

TKI - September 2020

Exelixis submitted sNDA to FDA for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) for advanced renal cell carcinoma

24 Aug 2020

Cabometyx (Cabozantinib; Met kinase inhibitor) – Exelixis

  • Submission is based on the pivotal Phase 3  CheckMate-9ER trial, which met its primary endpoint of significantly improving progression-free survival at final analysis and secondary endpoints of OS and ORR at a pre-specified interim analysis
  • Detailed results of CheckMate-9ER will be presented at ESMO 2020 (Presidential Symposium II on Sep 20, 2020)

Supplemental NDA submitted to FDA for Cabometyx + Opdivo in 1L advanced RCC

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CI Scientists Remarks: 

  • Cabometyx, is approved in the US as monotherapy for advanced RCC and HCC patients who have been previously treated with Sorafenib
  • CheckMate-9ER is an open-label, randomized, multi-national Phase 3 trial evaluating Cabometyx + Opdivo vs sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma
  • Immune checkpoint inhibitors (ICI) combinations with 75% market share dominate the 1L mRCC space. The approval of this combination will have significant growth opportunity for Cabometyx in 1L space and also as a approved product for 2L RCC, growth will be continued as patients treated with ICI regimens progress
  • Apart from this, Cabometyx is also being evaluated in wide range of cancers across different lines of therapy and combinations (NSCLC, mCRPC, HCC, RCC)

– Dr. Kowndinya, CI Scientists

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