Roche Gets Nod for Expanded Use of Columvi in Lymphoma in Europe

Roche RHHBY announced that the European Commission has approved its lymphoma drug, Columvi (glofitamab), for second-line treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (“DLBCL”).The regulatory body in Europe has now approved Columvi in combination with gemcitabine and oxaliplatin (GemOx) for treating R/R DLBCL in adult patients who are not otherwise specified or eligible for autologous stem cell transplant.The approval in the European Union was expected as the Committee for Medicinal Products for Human Use recommended approval for Columvi in the given setting in February.Columvi is also under review in the United States for a similar indication. A final decision from the FDA is expected on July 20, 2025.RHHBY's Price PerformanceYear to date, shares of Roche have risen 9.3% against the industry’s decline of 6.7%.Image Source: Zacks Investment ResearchLatest EU Nod for Columvi Based on RHHBY's STARGLO StudyThe latest approval for the Columvi combo for second-line R/R DLBCL was based on data from the pivotal phase III STARGLO study.Data from the same showed that treatment with Columvi in combination with GemOx led to a statistically significant and clinically meaningful improvement in overall survival compared with MabThera/Rituxan (rituximab) with GemOx. This makes it the first CD20xCD3 bispecific antibody to show a survival benefit in DLBCL in patients whose cancer returned after first-line therapy.Treatment with Columvi plus GemOx demonstrated a 41% reduction in the risk of death versus R-GemOx.The Columvi/GemOx combo demonstrated a safety profile consistent with the individual medicines.Please note that Columvi is 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 European Union and is currently approved in more than 50 countries worldwide for the same indication.Importantly, the latest nod in the European Union for Columvi (second-line setting) fulfills a condition to convert the existing marketing authorization to full approvals for third-line R/R DLBCL in the country.DLBCL is the most common form of non-Hodgkin’s lymphoma (“NHL”) and aggressive (fast-growing) in nature. It accounts for approximately one-third of all NHL cases. An estimated 160,000 people are diagnosed with DLBCL every year, globally.Roche is also 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).RHHBY's Zacks Rank & Stocks to ConsiderRoche currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Krystal Biotech, Inc. KRYS and ADMA Biologics, Inc. ADMA, 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.In the past 60 days, estimates for Jazz Pharmaceuticals’ earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.35. Year to date, shares of JAZZ have lost 18.4%.JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.40 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have gained 5.4%.KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.In the past 60 days, estimates for ADMA Biologics’ earnings per share have increased from 69 cents to 71 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 87 cents to 93 cents. Year to date, shares of ADMA have risen 13.2%.ADMA’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 32.80%.5 Stocks Set to DoubleEach was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report ADMA Biologics Inc (ADMA): Free Stock Analysis Report Krystal Biotech, Inc. (KRYS): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks