FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review
Contrasts With EMA Decision
Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first
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The company is getting more attention these days for its TIGIT inhibitor tiragolumab in combination with Tecentriq for 1L NSCLC, but a new 1L monotherapy indication for Tecentriq helps it compete against Keytruda.
Overall, the pharma lowered its 2020 revenue guidance by $2.5bn at the midpoint, but also says it will save about $400m on SG&A expenses. Pandemic impacts expected mainly in Q2, normal resumption in Q4.
EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.