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Roche received the EU’s CHMP Positive Opinion for subcutaneous injection of Tecentriq to treat multiple types of cancer

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Roche received the EU’s CHMP Positive Opinion for subcutaneous injection of Tecentriq to treat multiple types of cancer

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  • 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

Related News:- Genentech Reports Second Interim Analysis Results from the P-III Study (SKYSCRAPER-01) of Tiragolumab + Tecentriq for PD-L1-High Metastatic Non-Small Cell Lung Cancer

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Shivani Chandra

Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.

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