The EU’s CHMP had adopted positive opinion for the approval of Tecentriq based on Phase IB/III (IMscin001) study evaluating PK, safety & efficacy of the Tecentriq SC, vs Tecentriq IV, in treated locally advanced or metastatic NSCLC patients (n=371) who have failed prior platinum therapy
The result demonstrated consistency in efficacy measured by OS with median follow up of 9.5mos., PFS & ORR and safety, in both formulation, additionally exhibiting equivalent levels of Tecentriq in the blood over a particular dosage interval based on known PK parameters
Tecentriq SC, which has got its first marketing authorization in the UK is the mAb that binds to the PD-L1, & blocks its interactions with both the PD-1 and B7.1 receptors
Ref: Globenewswire | Image: Roche
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