Roche Wins FDA Nod for Label Expansion of Tecentriq in Lung Cancer

Roche RHHBY announced that the FDA approved the label expansion of immunotherapy drug Tecentriq (atezolizumab).

The FDA approved Tecentriq and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with Jazz Pharmaceuticals’ JAZZ Zepzelca (lurbinectedin) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide.

Per Roche, this approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC.

Roche’s shares have risen 32.5% year to date compared with the industry’s growth of 10.7%.

More on RHHBY’s Tecentriq 

The latest FDA approval is based on results from the late-stage IMforte study, which showed that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone.

The median overall survival for the combination regimen was 13.2 months versus 10.6 months for Tecentriq alone, following 3.2 months of induction therapy.

The approval of this combination therapy provides a new option and a proactive approach in this setting and helps address the high rate of relapse in ES-SCLC.

Moreover, the U.S. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.

We note that the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC in 2019.

Tecentriq is approved in several countries either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic non-small cell lung cancer, 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 sales totaled CHF 1.7 billion in the first half of 2025.

JAZZ’s Zepzelca is an alkylating drug that binds guanine residues within DNA. The FDA approved Zepzelca in 2020 under accelerated approval for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy.

RHHBY’s Strong Portfolio Drives Growth

Roche’s performance in the first half of 2025 was good, as high demand for key drugs offset the decline in sales of legacy drugs.

Sales in the Pharmaceuticals Division grew 10% in the first half to CHF 24 billion, driven by strong growth in demand for its key drugs — Phesgo (breast cancer), Xolair (food allergies), Hemlibra (hemophilia A), Vabysmo and Ocrevus (multiple sclerosis).

RHHBY recently announced that it will acquire clinical-stage biopharmaceutical company 89bio, Inc. ETNB for $3.5 billion, aiming to augment its portfolio in cardiovascular, renal, and metabolic diseases (CVRM).

The acquisition will add 89bio’s pegozafermin to RHHBY’s pipeline. Pegozafermin is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21), currently in late-stage development for metabolic dysfunction-associated steatohepatitis (MASH) in moderate and severe fibrotic patients (F2 and F3 stages) as well as cirrhotic patients (F4 stage).

However, pipeline setbacks weigh on the stock. Roche earlier announced that the phase III ARNASA study on chronic obstructive pulmonary disease candidate astegolimab did not meet the primary endpoint of a statistically significant reduction in the annualized exacerbation rate (“AER”) at 52 weeks.

Nonetheless, the phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the AER at 52 weeks when astegolimab was given every two weeks.

The performance of the Diagnostic division was also disappointing.

RHHBY’s Zacks Rank

Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 

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