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Roche (RHHBY) Polivy Combo Backed by FDA Advisory Committee
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Roche (RHHBY - Free Report) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).
The ODAC voted 11 to 2 in favor of the Polivy combination. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, though the FDA is not bound by them.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC).
The FDA is expected to make a final decision on its review of the supplemental Biologics License Application (sBLA) for Polivy in this indication by Apr 2, 2023.
The sBLA submission is based on data from the phase III POLARIX study, which demonstrated a statistically significant and clinically meaningful improvement in PFS with Polivy plus R-CHP compared to standard-of-care R-CHOP in first-line DLBCL.
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL) and accounts for about one in three cases of NHL.
We note that Polivy in combination with bendamustine and MabThera/Rituxan, is currently approved worldwide for the treatment of adults with relapsed or refractory DLBCL after one or more prior therapies, including in the United States under FDA accelerated approval, as a readily available, fixed-duration treatment option.
A potential label expansion will boost the sales potential of the drug.
Roche’s hematology portfolio comprises approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Polivy, Venclexta/Venclyxto, Hemlibra and Lunsumio and a pipeline of investigational haematology medicines, including T-cell engaging bispecific antibodies glofitamab, targeting both CD20 and CD3 and cevostamab, targeting both FcRH5 and CD3.
Roche’s stock has lost 22.8% in the past year against the industry’s growth of 4.5%.
Image Source: Zacks Investment Research
Roche’s performance was hurt by significantly lower COVID-19-related sales, which impacted the top line even though new drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, recorded growth. The uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
2023 is also expected to be challenging for the company due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Allogene’s loss per share estimates narrowed from $2.86 to $2.57 in the past 60 days. ALLO beat earnings estimates in all the last four reported quarters.
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Roche (RHHBY) Polivy Combo Backed by FDA Advisory Committee
Roche (RHHBY - Free Report) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted in favor of Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL).
The ODAC voted 11 to 2 in favor of the Polivy combination. The ODAC provides the FDA with independent opinions and recommendations from outside medical experts, though the FDA is not bound by them.
Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC).
The FDA is expected to make a final decision on its review of the supplemental Biologics License Application (sBLA) for Polivy in this indication by Apr 2, 2023.
The sBLA submission is based on data from the phase III POLARIX study, which demonstrated a statistically significant and clinically meaningful improvement in PFS with Polivy plus R-CHP compared to standard-of-care R-CHOP in first-line DLBCL.
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL) and accounts for about one in three cases of NHL.
We note that Polivy in combination with bendamustine and MabThera/Rituxan, is currently approved worldwide for the treatment of adults with relapsed or refractory DLBCL after one or more prior therapies, including in the United States under FDA accelerated approval, as a readily available, fixed-duration treatment option.
A potential label expansion will boost the sales potential of the drug.
Roche’s hematology portfolio comprises approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Polivy, Venclexta/Venclyxto, Hemlibra and Lunsumio and a pipeline of investigational haematology medicines, including T-cell engaging bispecific antibodies glofitamab, targeting both CD20 and CD3 and cevostamab, targeting both FcRH5 and CD3.
Roche’s stock has lost 22.8% in the past year against the industry’s growth of 4.5%.
Image Source: Zacks Investment Research
Roche’s performance was hurt by significantly lower COVID-19-related sales, which impacted the top line even though new drugs, namely Ocrevus, Hemlibra, Evrysdi and Tecentriq, recorded growth. The uptake of the new eye drug Vabysmo (launched at the beginning of 2022) was outstanding.
2023 is also expected to be challenging for the company due to the expected sharp decline in sales of COVID-19 products of roughly CHF 5 billion.
Some better-ranked stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Allogene Therapeutics (ALLO - Free Report) . While Novo sports a Zacks Rank #1 (Strong Buy) at present, ALLO carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Allogene’s loss per share estimates narrowed from $2.86 to $2.57 in the past 60 days. ALLO beat earnings estimates in all the last four reported quarters.