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 Nod for Expanded Use of Columvi in Lymphoma in Europe
Read MoreHide Full Article
Roche (RHHBY - Free Report) 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 Performance
Year to date, shares of Roche have risen 9.3% against the industry’s decline of 6.7%.
Image Source: Zacks Investment Research
Latest EU Nod for Columvi Based on RHHBY's STARGLO Study
The 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).
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%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Roche Gets Nod for Expanded Use of Columvi in Lymphoma in Europe
Roche (RHHBY - Free Report) 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 Performance
Year to date, shares of Roche have risen 9.3% against the industry’s decline of 6.7%.
Image Source: Zacks Investment Research
Latest EU Nod for Columvi Based on RHHBY's STARGLO Study
The 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 Consider
Roche currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. (JAZZ - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , 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%.