Lilly and Innovent look to bring their anti-PD-1 from China to the US; Merck KGaA names new EMD Serono president
After winning two regulatory approvals in China for a PD-1 inhibitor, Eli Lilly and Innovent are looking to bring the drug to the US.
The pair submitted their BLA for sintilimab, branded as Tyvyt in China, in combination with pemetrexed and platinum chemo on Tuesday for the first-line treatment on nonsquamous NSCLC. The application comes on the heels of a Phase III trial where patients in the drug arm saw a median progression-free survival of 8.9 months, as opposed to just five months among those taking the placebo.
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