Roche Receives European Commission Approval Of Tecentriq SC With Halozyme's ENHANZE Representing The EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy For Multiple Cancer Types
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The European Commission has approved Roche's Tecentriq SC, a subcutaneous (SC) formulation of its cancer immunotherapy, which uses Halozyme's ENHANZE technology. This approval marks the EU's first subcutaneous PD-(L)1 cancer immunotherapy for multiple cancer types. The SC injection, which reduces treatment time by approximately 80% compared to standard IV infusion, is preferred by patients and healthcare practitioners due to its convenience and potential time savings for healthcare systems. The approval is based on the Phase IB/III IMscin001 study, demonstrating comparable blood levels of Tecentriq and a consistent safety and efficacy profile to the IV formulation.
January 16, 2024 | 6:57 am
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POSITIVE IMPACT
Halozyme's ENHANZE technology is integral to the newly approved Tecentriq SC, which may lead to increased royalties or revenue from Roche.
Halozyme's technology being part of the first subcutaneous PD-(L)1 cancer immunotherapy approved in the EU could result in increased usage and royalties. This partnership with Roche and the approval could positively impact Halozyme's financials in the short term.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 70
POSITIVE IMPACT
Roche's Tecentriq SC has received approval from the European Commission, potentially increasing its market share in the EU for cancer immunotherapy treatments.
The approval of Tecentriq SC in the EU is a significant milestone for Roche, likely to boost its competitive edge in the cancer treatment market. The convenience of SC administration could lead to increased preference for Tecentriq, potentially driving up short-term demand and stock price.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90