Roche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded use of Columvi (glofitamab) for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for review. The eligible population includes DLBCL patients who have received at least one prior line of treatment (second-line setting) and are not candidates for autologous stem cell transplant. A final decision from the regulatory body is expected on July 20, 2025.

Please note that Columvi is already approved in the United States under the FDA’s accelerated approval pathway as a monotherapy for treating people with R/R DLBCL after two or more lines of systemic therapy (third-line setting). The drug has also received conditional marketing authorization in the EU and is currently approved in more than 50 countries globally for the same indication.

Columvi is a first-of-its-kind CD20xCD3 T-cell-engaging bispecific antibody with a novel mechanism of action. Per RHHBY, the drug has been used to treat over 3,000 patients in clinical studies and more than 2,600 in real-world practice.

In the past three months, shares of Roche have lost 11.4% compared with the industry’s 11.8% decline.

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More on the FDA Acceptance of RHHBY’s Columvi sBLA

Roche’s sBLA for the Columvi, in combination with gemcitabine and oxaliplatin (GemOx), to treat second-line R/R DLBCL is supported by findings from the phase III STARGLO study. The combination therapy showed a statistically significant and clinically meaningful improvement in overall survival compared to MabThera/Rituxan (rituximab) with GemOx, making it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in a randomized phase III study. The Columvi/GemOx combo was well-tolerated and demonstrated a safety profile consistent with the individual medicines.

The current standard of care (SOC) for second-line R/R DLBCL is high-dose chemotherapy followed by stem-cell transplant. However, many patients are ineligible for this approach due to factors like age or underlying health conditions. Although newer therapies are emerging, significant barriers persist, highlighting the need for alternative treatment options to enhance survival outcomes.

Roche believes in the potential of the Columvi combo therapy to replace the current SOC given the significant survival benefit observed in the STARGLO study. The company has also submitted study data to other regulatory bodies around the world for approval consideration, including in the EU.

The STARGLO study is designed as a confirmatory study to convert the accelerated approval of Columvi in the United States and conditional marketing authorization in the EU to full approvals for third-line R/R DLBCL. Roche is also currently evaluating Columvi in combination with Polivy (elotuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone in the phase III SKYGLO study to treat previously untreated DLBCL patients (first-line setting).

DLBCL is the most common form of non-Hodgkin’s lymphoma (NHL) and is aggressive (fast-growing) in nature. DLBCL accounts for approximately one-third of all NHL cases. An estimated number of 160,000 people are diagnosed with DLBCL every year, globally. NHL is a type of B-cell malignancy that begins in damaged B cells and affects the lymphatic system, which is part of the immune system.

Roche Holding AG Price and Consensus

Roche Holding AG price-consensus-chart | Roche Holding AG Quote

RHHBY’s Zacks Rank & Stocks to Consider

Roche currently carries a Zacks Rank #3 (Hold).

Some better-ranked pharma stocks are Halozyme Therapeutics HALO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Halozyme Therapeutics’ earnings estimates have risen from $3.95 to $4.05 per share for 2024, while that for 2025 has increased from $4.73 to $4.80. HALO shares have lost 17.9% in the past three months.

Halozyme Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 14.86%.

In the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 11.7% in the past three months.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

In the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 16.3% in the past three months.

Gilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.

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