Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?
Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.
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The company has filed its first drug in the UK and initiated a US-based Phase III trial; US drug pricing legislation underscores the company's value proposition, CEO argues, since payers will still be under pressure.
The official verdict is in for sintilimab and the results are not surprising. But some view the setback for "Made In China" innovation as a chance to reflect and move forward.
China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.