{"id":11493,"date":"2023-11-15T10:03:00","date_gmt":"2023-11-15T02:03:00","guid":{"rendered":"https:\/\/flcube.com\/?p=11493"},"modified":"2024-11-13T23:09:37","modified_gmt":"2024-11-13T15:09:37","slug":"emas-chmp-issues-positive-opinion-for-roches-tecentriq-sc-subcutaneous-formulation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=11493","title":{"rendered":"EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation"},"content":{"rendered":"\n

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of cancer, as the recommendation encompasses all current indications for the intravenous (IV) form of Tecentriq, including lung, liver, bladder, and breast cancers.<\/p>\n\n\n\n

Advantages of Tecentriq SC<\/strong>
Tecentriq SC offers a more convenient administration option compared to the IV formulation. While an IV drip can take 30 to 60 minutes to administer, the subcutaneous injection of Tecentriq SC can be completed in just 7 minutes. This efficiency is attributed to the use of a proprietary hyaluronidase (rHuPH20) from Roche’s partner, Halozyme Therapeutics (NASDAQ: HALO<\/a>). The same technology is also utilized by Bristol Myers Squibb (BMS; NYSE: BMY<\/a>) for its subcutaneous anti-PD-1 drug Opdivo (nivolumab).<\/p>\n\n\n\n

Supporting Evidence and Approval Process<\/strong>
CHMP\u2019s endorsement is supported by data from a Phase Ib\/III trial that demonstrated the equivalence of the two Tecentriq formulations in terms of blood levels, safety, and efficacy. According to the public data, these results contributed to the approval of Tecentriq SC in the UK earlier this year, paving the way for its potential approval across the European Union.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA)…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[429,428,16,1425,1578,849,18,15,163,939],"class_list":["post-11493","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-halozyme-therapeutics","tag-nasdaq-halo","tag-nyse-bmy","tag-pd-1-l1","tag-product-approvals","tag-roche","tag-swx-rop"],"yoast_head":"\nEMA's CHMP Issues Positive Opinion for Roche's Tecentriq SC Subcutaneous Formulation - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche's (SWX: ROG) PD-L1 inhibitor Tecentriq. 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