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Roche's (RHHBY) Tecentriq Gets FDA Nod for Another Indication (Revised)
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Roche (RHHBY - Free Report) recently announced that the FDA has approved immuno-oncology drug Tecentriq (atezolizumab) for another indication.
Tecentriq is now approved as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test.
The approval was based on results from an interim analysis of the phase III IMpower010 study. Data from the study showed treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death by 34% in patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumors express PD-L1≥1% compared with best supportive care.
Data from the study has also been submitted as the basis of marketing applications to the European Medicines Agency (“EMA”) and other global health authorities. The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.
Approval in additional indications will boost sales of the drug that came in at CHF 1.6 billion in the first half of 2021.
Tecentriq is already approved for various types of lung cancer. It is approved as the front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.
Shares of Roche have gained 11.6% so far this year compared with the industry’s growth of 9%.
Image Source: Zacks Investment Research
Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across different settings in the lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. Tecentriq is being evaluated both as a standalone treatment and in combination with other medicines, as well as studies in metastatic, adjuvant, and neoadjuvant settings across various tumor types.
In addition to Tecentriq, Roche’s cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualized neoantigen therapies and T-cell bispecific antibodies.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s (MRK - Free Report) Keytruda and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for some of these indications.
Image: Bigstock
Roche's (RHHBY) Tecentriq Gets FDA Nod for Another Indication (Revised)
Roche (RHHBY - Free Report) recently announced that the FDA has approved immuno-oncology drug Tecentriq (atezolizumab) for another indication.
Tecentriq is now approved as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test.
The approval was based on results from an interim analysis of the phase III IMpower010 study. Data from the study showed treatment with Tecentriq, following surgery and platinum-based chemotherapy, reduced the risk of disease recurrence or death by 34% in patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumors express PD-L1≥1% compared with best supportive care.
Data from the study has also been submitted as the basis of marketing applications to the European Medicines Agency (“EMA”) and other global health authorities. The review of this application was conducted under the FDA’s Project Orbis initiative, which provides a framework for concurrent submission and review of oncology medicines among international partners.
Approval in additional indications will boost sales of the drug that came in at CHF 1.6 billion in the first half of 2021.
Tecentriq is already approved for various types of lung cancer. It is approved as the front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.
Shares of Roche have gained 11.6% so far this year compared with the industry’s growth of 9%.
Roche is also evaluating Tecentriq in multiple ongoing and planned phase III studies across different settings in the lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. Tecentriq is being evaluated both as a standalone treatment and in combination with other medicines, as well as studies in metastatic, adjuvant, and neoadjuvant settings across various tumor types.
In addition to Tecentriq, Roche’s cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualized neoantigen therapies and T-cell bispecific antibodies.
While the uptake of Tecentriq has been strong, it is currently facing stiff competition from immuno-oncology therapies like Merck’s (MRK - Free Report) Keytruda and Bristol-Myers’ (BMY - Free Report) Opdivo in various indications. AstraZeneca’s (AZN - Free Report) Imfinzi is also approved for some of these indications.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
(We are reissuing this article to correct a mistake. The original article, issued on October 18, 2021, should no longer be relied upon.)