We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Roche Gets FDA Approval for Another Label Expansion of Tecentriq
Read MoreHide Full Article
Key Takeaways
Roche secured FDA approval for Tecentriq in combination with chemotherapy for stage III dMMR colon cancer.
The phase III ATOMIC study showed a 50% lower risk of recurrence or death with Tecentriq plus chemotherapy.
Tecentriq's latest approval marks its 12th U.S. indication as Roche advances its broader oncology pipeline.
Roche (RHHBY - Free Report) has secured yet another label expansion for its cancer immunotherapy Tecentriq (atezolizumab) in the United States.
The FDA approved Tecentriq and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with fluoropyrimidine and oxaliplatin chemotherapy for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer.
The approval marks the 12th U.S. indication for Tecentriq and strengthens Roche’s oncology portfolio by expanding its reach into an important treatment setting where the risk of cancer recurrence remains high.
Year to date, shares of Roche have risen 3.5% compared with the industry’s rise of 11%.
Image Source: Zacks Investment Research
More on RHHBY’s Tecentriq Latest Approval
The FDA decision was based on the phase III ATOMIC study, which enrolled 712 patients with stage III dMMR colon cancer. The trial evaluated the addition of Tecentriq to modified (m) FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair.
The study demonstrated that adding Tecentriq reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. The 36-month disease-free survival rate was 86% for patients receiving Tecentriq plus chemotherapy, compared with 76% for those receiving chemotherapy alone. The safety profile was consistent with previous studies of Tecentriq and modified FOLFOX6.
The latest approval makes Tecentriq the first approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning it as a new post-surgery standard of care.
Colon cancer represents a substantial global healthcare burden, with more than 1 million people diagnosed worldwide each year. Nearly one-quarter of colon cancer cases are diagnosed at stage III, and approximately 30% of patients with stage III disease experience recurrence within five years despite surgery and chemotherapy.
By addressing this unmet need, Roche gains an opportunity to expand Tecentriq’s role in earlier cancer treatment.
Roche plans to pursue additional regulatory filings for Tecentriq, including a submission to the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide.
Tecentriq is already approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
The drug generated sales of CHF 1.7 billion in the first half of 2026, up 6%.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted the company’s new drug application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Upon potential approval, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS.
Last month, RHHBY reported positive prespecified interim results from the ongoing phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN).
The study met its primary endpoint, with sefaxersen demonstrating statistically significant and clinically meaningful reductions in proteinuria compared with placebo at 37 weeks, as measured by the 24-hour urine protein-to-creatinine ratio.
Roche reported encouraging top-line results from a mid-stage study of enicepatide (CT-388), its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes (T2D) and overweight or obesity.
Enicepatide met both primary endpoints at 48 weeks, delivering dose-dependent reductions in HbA1c and body weight.
The encouraging results strengthen Roche’s prospects of establishing a foothold in the rapidly expanding obesity and metabolic disease market.
The efficacy profile is encouraging as Roche seeks to compete in the increasingly crowded incretin market, which includes established therapies from Eli Lilly and Novo Nordisk.
Roche is advancing a broad late-stage development program for enicepatide, with two ongoing phase III studies in chronic weight management (ENITH-1 and ENITH-2). The company plans to initiate a phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027.
Over the past 60 days, estimates for Pfizer’s 2026 earnings per share have risen from $2.97 to $2.98, while those for 2027 EPS have increased from $2.94 to $2.95. PFE’s shares have surged 12.5% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.62%.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.28 to $1.29 over the past 60 days.
View the Zacks #1 Rank List
Image: Bigstock
Roche Gets FDA Approval for Another Label Expansion of Tecentriq
Key Takeaways
Roche (RHHBY - Free Report) has secured yet another label expansion for its cancer immunotherapy Tecentriq (atezolizumab) in the United States.
The FDA approved Tecentriq and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with fluoropyrimidine and oxaliplatin chemotherapy for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer.
The approval marks the 12th U.S. indication for Tecentriq and strengthens Roche’s oncology portfolio by expanding its reach into an important treatment setting where the risk of cancer recurrence remains high.
Year to date, shares of Roche have risen 3.5% compared with the industry’s rise of 11%.
Image Source: Zacks Investment Research
More on RHHBY’s Tecentriq Latest Approval
The FDA decision was based on the phase III ATOMIC study, which enrolled 712 patients with stage III dMMR colon cancer. The trial evaluated the addition of Tecentriq to modified (m) FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair.
The study demonstrated that adding Tecentriq reduced the risk of disease recurrence or death by 50% compared to chemotherapy alone. The 36-month disease-free survival rate was 86% for patients receiving Tecentriq plus chemotherapy, compared with 76% for those receiving chemotherapy alone. The safety profile was consistent with previous studies of Tecentriq and modified FOLFOX6.
The latest approval makes Tecentriq the first approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning it as a new post-surgery standard of care.
Colon cancer represents a substantial global healthcare burden, with more than 1 million people diagnosed worldwide each year. Nearly one-quarter of colon cancer cases are diagnosed at stage III, and approximately 30% of patients with stage III disease experience recurrence within five years despite surgery and chemotherapy.
By addressing this unmet need, Roche gains an opportunity to expand Tecentriq’s role in earlier cancer treatment.
Roche plans to pursue additional regulatory filings for Tecentriq, including a submission to the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide.
Tecentriq is already approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
The drug generated sales of CHF 1.7 billion in the first half of 2026, up 6%.
RHHBY’s Efforts to Diversify Pipeline
Strong growth from key drugs like Ocrevus, Vabysmo, Hemlibra and Phesgo has helped RHHBY offset declining revenues from legacy drugs.
Roche has a strong and diversified pipeline spanning multiple therapeutic modalities.
The FDA recently accepted the company’s new drug application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Upon potential approval, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS.
Last month, RHHBY reported positive prespecified interim results from the ongoing phase III IMAgINATION study evaluating investigational sefaxersen in adults with primary IgA nephropathy (IgAN).
The study met its primary endpoint, with sefaxersen demonstrating statistically significant and clinically meaningful reductions in proteinuria compared with placebo at 37 weeks, as measured by the 24-hour urine protein-to-creatinine ratio.
Roche reported encouraging top-line results from a mid-stage study of enicepatide (CT-388), its investigational once-weekly dual GLP-1/GIP receptor agonist, in adults with type 2 diabetes (T2D) and overweight or obesity.
Enicepatide met both primary endpoints at 48 weeks, delivering dose-dependent reductions in HbA1c and body weight.
The encouraging results strengthen Roche’s prospects of establishing a foothold in the rapidly expanding obesity and metabolic disease market.
The efficacy profile is encouraging as Roche seeks to compete in the increasingly crowded incretin market, which includes established therapies from Eli Lilly and Novo Nordisk.
Roche is advancing a broad late-stage development program for enicepatide, with two ongoing phase III studies in chronic weight management (ENITH-1 and ENITH-2). The company plans to initiate a phase III glycemic-control program and cardiovascular outcomes trials in the first half of 2027.
RHHBY’s Zacks Rank and Stocks to Consider
Roche currently has a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the large-cap pharma sector are Pfizer (PFE - Free Report) and Bayer (BAYRY - Free Report) , both currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Pfizer’s 2026 earnings per share have risen from $2.97 to $2.98, while those for 2027 EPS have increased from $2.94 to $2.95. PFE’s shares have surged 12.5% year to date.
Pfizer’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.62%.
Shares of Bayer have gained 13.3% year to date. Estimates for BAYRY’s 2026 EPS have increased from $1.28 to $1.29 over the past 60 days.