Bristol Falls Further Behind Merck In NSCLC By Pulling Early Combo Filing
Bristol-Myers Squibb's decision not to seek accelerated FDA approval for its Opdivo/Yervoy combo in early lung cancer shocked investors - but analysts still expect a filing to come, albeit later than first thought.
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The combination of Opdivo and Yervoy showed a survival advantage in renal cancer in a Phase III trial, adding to the understanding that overall survival may be a better endpoint than progression-free survival for measuring immuno-oncology drugs.
The pursuit by the industry to find novel combinations that can address more patients and more tumor types has driven overall immuno-oncology deal activity by big pharma and mid pharma companies between 2012 and 2016.
Opdivo first-quarter sales were still strong at $1.1bn, largely driven by lung cancer use and helping to drive overall performance, but potential approval of Merck's competing Keytruda with chemotherapy in first-line lung cancer is right around the corner.