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RCC [2017]: Bulletin #2

Introduction

This edition presents key opinion leader (KOL) views on recent developments in the renal cell carcinoma (RCC) market. Topics covered include; the early halting of the CheckMate-214 trial and subsequent regulatory applications for Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with ipilimumab (Yervoy), in intermediate- and poor-risk patients with previously untreated advanced or metastatic RCC; the European Medicines Agency (EMA) approval of AVEO Oncology’s Fotivda (tivozanib) in advanced RCC; the US FDA extending the approval of Pfizer’s Sutent (sunitinib) to include the adjuvant treatment of high-risk recurrent RCC, following nephrectomy, based on data from the Phase III S-TRAC trial.

Business Questions:

How do KOLs view the news of a positive outcome from the CheckMate-214 trial of Opdivo/ipilimumab?

Do KOLs anticipate that Opdivo/ipilimumab will become a standard of care in intermediate- and poor-risk patients with previously untreated advanced or metastatic RCC?

What factors are anticipated to impact Opdivo/ipilimumab’s chances of success in the treatment of RCC?

How do KOLs view Fotivda compared with other available TKIs?

How will do KOLs view Fotivda’s chances of success in the EU?

Could Fotivda play a significant role in the future of RCC treatment in the US?

How do KOLs view the FDA decision to approve Sutent for the adjuvant treatment of high-risk recurrent RCC, following nephrectomy?

Will Sutent’s toxicity issues be manageable in the adjuvant setting?

To what extent and in which patients is Sutent expected to be used in the adjuvant setting, and what could help it establish broader use?


Please Note: Due to the brevity and/or nature of the content posted, there is no table of contents available for this report.

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