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Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq
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Roche (RHHBY - Free Report) announced that the FDA has approved the subcutaneous (SC) formulation of the blockbuster immunotherapy drug Tecentriq (atezolizumab).
The SC formulation was approved under the brand name Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs).
Per Roche, the approval makes Tecentriq Hybreza the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the United States.
Year to date, Roche’s shares have gained 8% compared with the industry’s 25.4% growth.
Image Source: Zacks Investment Research
Roche’s Tecentriq SC Approval
Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
The FDA approval was based on data from the phase IB/III IMscin001 study. Data from the study showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the intravenous (IV) formulation.
The mid-stage IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over IV infusion.
The new SC option reduces treatment time to approximately seven minutes compared with 30-60 minutes for IV infusion.
The SC formulation will be available for all indications of Tecentriq approved for adults in the United States, including certain types of lung, liver, skin and soft tissue cancer.
It was first approved in Great Britain in August 2023 and is now approved in 50 countries.
Tecentriq: A Top Drug for Roche
Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) small cell lung cancer (NSCLC), small cell lung cancer and hepatocellular carcinoma.
The drug is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma.
Tecentriq is one of the top revenue generators for Roche. Sales of the drug totaled CHF 1.8 billion in the first half of 2024.
However, the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq and chemotherapy versus Merck’s (MRK) Keytruda (pembrolizumab) and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous NSCLC, did not meet its primary endpoints of progression-free survival at its primary analysis and overall survival at first interim analysis.
Merck’s Keytruda is the leading immuno-oncology treatment in the world. It is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales. Keytruda generated sales of more than $14 billion in the first half of 2024.
Estimates for Eli Lilly’s 2024 earnings have risen from $15.77 to $16.49 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $22.19 to $23.97 over the same time frame. Year to date, Lilly’s shares have risen 60.3%.
Estimates for NVS’ 2024 earnings have risen from $7.48 to $7.50 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $8.27 to $8.30 over the same time frame.
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Roche Gets FDA Approval for Subcutaneous Formulation of Tecentriq
Roche (RHHBY - Free Report) announced that the FDA has approved the subcutaneous (SC) formulation of the blockbuster immunotherapy drug Tecentriq (atezolizumab).
The SC formulation was approved under the brand name Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs).
Per Roche, the approval makes Tecentriq Hybreza the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the United States.
Year to date, Roche’s shares have gained 8% compared with the industry’s 25.4% growth.
Image Source: Zacks Investment Research
Roche’s Tecentriq SC Approval
Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
The FDA approval was based on data from the phase IB/III IMscin001 study. Data from the study showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the intravenous (IV) formulation.
The mid-stage IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over IV infusion.
The new SC option reduces treatment time to approximately seven minutes compared with 30-60 minutes for IV infusion.
The SC formulation will be available for all indications of Tecentriq approved for adults in the United States, including certain types of lung, liver, skin and soft tissue cancer.
It was first approved in Great Britain in August 2023 and is now approved in 50 countries.
Tecentriq: A Top Drug for Roche
Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) small cell lung cancer (NSCLC), small cell lung cancer and hepatocellular carcinoma.
The drug is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma.
Tecentriq is one of the top revenue generators for Roche. Sales of the drug totaled CHF 1.8 billion in the first half of 2024.
However, the phase II/III SKYSCRAPER-06 study, evaluating tiragolumab plus Tecentriq and chemotherapy versus Merck’s (MRK) Keytruda (pembrolizumab) and chemotherapy as an initial (first-line) treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous NSCLC, did not meet its primary endpoints of progression-free survival at its primary analysis and overall survival at first interim analysis.
Merck’s Keytruda is the leading immuno-oncology treatment in the world. It is already approved for the treatment of many cancers globally and accounts for around 50% of Merck’s pharmaceutical sales. Keytruda generated sales of more than $14 billion in the first half of 2024.
Roche’s Rank & Other Key Picks
Roche currently has a Zacks Rank #2 (Buy).
Some other top-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Novartis (NVS - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $15.77 to $16.49 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $22.19 to $23.97 over the same time frame. Year to date, Lilly’s shares have risen 60.3%.
Estimates for NVS’ 2024 earnings have risen from $7.48 to $7.50 per share over the past 30 days. For 2025, the bottom-line estimate has risen from $8.27 to $8.30 over the same time frame.