Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq

Core Viewpoint - Roche has received FDA approval for the subcutaneous formulation of its immunotherapy drug Tecentriq, branded as Tecentriq Hybreza, making it the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the United States [1][4]. Roche's Tecentriq SC Approval - The subcutaneous formulation combines Tecentriq with Halozyme Therapeutics' Enhanze drug delivery technology [4]. - Approval was based on data from the phase IB/III IMscin001 study, showing comparable blood levels of Tecentriq and a safety and efficacy profile consistent with the intravenous formulation [4]. - A mid-stage study (IMscin002) indicated that 71% of patients preferred the subcutaneous option over intravenous infusion [4]. - The new formulation reduces treatment time to approximately seven minutes compared to 30-60 minutes for intravenous infusion [5]. - The SC formulation will be available for all adult indications of Tecentriq in the U.S., including various cancers [5]. Tecentriq's Market Position - Tecentriq is a leading drug for Roche, with sales totaling CHF 1.8 billion in the first half of 2024 [7]. - It is approved for multiple cancer types globally, either alone or in combination with other therapies [6][7]. Competitive Landscape - The phase II/III SKYSCRAPER-06 study did not meet its primary endpoints when comparing tiragolumab plus Tecentriq to Merck's Keytruda [8]. - Keytruda is a leading immuno-oncology treatment, generating over $14 billion in sales in the first half of 2024 [9]. Roche's Current Standing - Roche holds a Zacks Rank 2 (Buy) [10]. - Comparatively, Eli Lilly has a Zacks Rank 1 (Strong Buy) and Novartis has a Zacks Rank 2 [10].