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Roche (RHHBY) Blood Cancer Drug Columvi Wins EC Approval
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Roche (RHHBY - Free Report) obtained conditional marketing authorization from the European Commission (EC) for its lymphoma drug Columvi (glofitamab).
The drug has been approved for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
The approval is based on results from the phase I/II NP30179 study, where Columvi, given as a fixed course, induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma.
The approval makes Columvi, the first CD20xCD3 T-cell-engaging bispecific antibody, available to treat patients in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy.
The FDA recently approved Columvi for the treatment of adult patients with R/R DLBCL, not otherwise specified or large B-cell lymphoma (LBCL) arising from FL after two or more lines of systemic therapy for the treatment of individuals with R/R large B-cell lymphoma. It is also approved in Canada and submissions to additional health authorities worldwide are ongoing.
Per Roche, Columvi has the potential to change the current standard of care in DLBCL as the drug is designed to be dosed for a fixed period of time, meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that individuals do not have to wait for cell collection and genetic engineering — a multistep process that can take several weeks — before starting treatment.
DLBCL, an aggressive (fast-growing) type of lymphoma, is one of the most prevalent types of blood cancer among adults.
Roche’s stock has lost 4.6% in the year so far compared with the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
Roche is evaluating Columvi in combination with other drugs as well. The company is investigating the potential of both Columvi and Lunsumio (mosunetuzumab) in earlier lines of treatment and in combination with other novel and chemotherapy-free agents, such as Polivy (polatuzumab vedotin), to provide patients with long-lasting outcomes.
We note that Lunsumio (mosunetuzumab-axgb) was granted accelerated approval by the FDA in December 2022 for treating adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.
In addition, the late-stage STARGLO trial is evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus DLBCL who are ineligible for autologous stem cell transplant. Additional phase III studies are also planned, including in first-line DLBCL.
Approval of new drugs bodes well for Roche, which boasts a strong hematology portfolio with drugs like MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy, Venclexta/Venclyxto (venetoclax), Hemlibra (emicizumab), and Lunsumio.
Roche’s performance in the first quarter was ordinary, as significantly lower COVID-19 product sales impacted the top line. However, new drugs — Ocrevus, Hemlibra, Evrysdi and Tecentriq — recorded growth and the uptake of the new eye drug, Vabysmo (launched at the beginning of 2022), was outstanding.
Sales are likely to be impacted further due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion in 2023. Competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin also harmed sales.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and AbbVie (ABBV - Free Report) . Ligand currently sports a Zacks Rank #1 (Strong Buy) and AbbVie carries a Zacks Rank #2 (Buy).
Over the past 60 days, earnings estimates for LGND have increased 46 cents to $5.25 for 2023. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, earnings estimates for ABBV have increased 3 cents to $10.99 for 2023. ABBV surpassed estimates in all the trailing four quarters, the average surprise being 1.78%.
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Roche (RHHBY) Blood Cancer Drug Columvi Wins EC Approval
Roche (RHHBY - Free Report) obtained conditional marketing authorization from the European Commission (EC) for its lymphoma drug Columvi (glofitamab).
The drug has been approved for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
The approval is based on results from the phase I/II NP30179 study, where Columvi, given as a fixed course, induced early and long-lasting complete responses in people with heavily pre-treated or refractory diffuse large B-cell lymphoma.
The approval makes Columvi, the first CD20xCD3 T-cell-engaging bispecific antibody, available to treat patients in Europe with the most common and aggressive form of lymphoma following multiple lines of therapy.
The FDA recently approved Columvi for the treatment of adult patients with R/R DLBCL, not otherwise specified or large B-cell lymphoma (LBCL) arising from FL after two or more lines of systemic therapy for the treatment of individuals with R/R large B-cell lymphoma. It is also approved in Canada and submissions to additional health authorities worldwide are ongoing.
Per Roche, Columvi has the potential to change the current standard of care in DLBCL as the drug is designed to be dosed for a fixed period of time, meaning that people have a target end date for their course of treatment and the possibility of a treatment-free period. It is also a chemotherapy-free treatment option that is off-the-shelf, meaning that individuals do not have to wait for cell collection and genetic engineering — a multistep process that can take several weeks — before starting treatment.
DLBCL, an aggressive (fast-growing) type of lymphoma, is one of the most prevalent types of blood cancer among adults.
Roche’s stock has lost 4.6% in the year so far compared with the industry’s decline of 1.6%.
Image Source: Zacks Investment Research
Roche is evaluating Columvi in combination with other drugs as well. The company is investigating the potential of both Columvi and Lunsumio (mosunetuzumab) in earlier lines of treatment and in combination with other novel and chemotherapy-free agents, such as Polivy (polatuzumab vedotin), to provide patients with long-lasting outcomes.
We note that Lunsumio (mosunetuzumab-axgb) was granted accelerated approval by the FDA in December 2022 for treating adult patients with R/R follicular lymphoma after two or more lines of systemic therapy.
In addition, the late-stage STARGLO trial is evaluating Columvi in combination with gemcitabine and oxaliplatin (GemOx) versus rituximab in combination with GemOx in patients with second-line plus DLBCL who are ineligible for autologous stem cell transplant. Additional phase III studies are also planned, including in first-line DLBCL.
Approval of new drugs bodes well for Roche, which boasts a strong hematology portfolio with drugs like MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Polivy, Venclexta/Venclyxto (venetoclax), Hemlibra (emicizumab), and Lunsumio.
Roche’s performance in the first quarter was ordinary, as significantly lower COVID-19 product sales impacted the top line. However, new drugs — Ocrevus, Hemlibra, Evrysdi and Tecentriq — recorded growth and the uptake of the new eye drug, Vabysmo (launched at the beginning of 2022), was outstanding.
Sales are likely to be impacted further due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion in 2023. Competition from biosimilars for established cancer medicines like Avastin, MabThera/Rituxan and Herceptin also harmed sales.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and AbbVie (ABBV - Free Report) . Ligand currently sports a Zacks Rank #1 (Strong Buy) and AbbVie carries a Zacks Rank #2 (Buy).
You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings estimates for LGND have increased 46 cents to $5.25 for 2023. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, earnings estimates for ABBV have increased 3 cents to $10.99 for 2023. ABBV surpassed estimates in all the trailing four quarters, the average surprise being 1.78%.