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Roche (RHHBY) Gets EC Approval for Polivy Combination in DLBCL

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Roche RHHBY recently announced that the European Commission (“EC”) has granted approval to lymphoma drug Polivy (polatuzumab vedotin) in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC).

The approval is based on data from the phase III POLARIX study, where Polivy plus R-CHP significantly improved progression-free survival with comparable safety versus the standard of care, R-CHOP.

DLBLC, an aggressive blood cancer, is the most common form of non-Hodgkin lymphoma (NHL).  Per the company, Polivy is the first new treatment option in more than two decades to show a clinically meaningful improvement in progression-free survival in previously untreated DLBCL.

In addition, the EC converted Polivy's initial conditional marketing authorization in the EU for the treatment of adult patients with relapsed or refractory DLBCL, who are not candidates for a hematopoietic stem cell transplant, to a full approval.

Polivy is being developed by Roche using Seagen’s SGEN ADC technology and is currently being evaluated for the treatment of several types of NHL.

Seagen receives royalties on worldwide net sales of Polivy.

Roche’s hematology portfolio comprises MabThera, Gazyvaro (obinutuzumab), Polivy, Venclyxto (venetoclax) in collaboration with AbbVie and Hemlibra (emicizumab) along with a pipeline of investigational haematology medicines, including T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3 and cevostamab, targeting both FcRH5 and CD3 among others.

Roche’s stock has lost 0.5% in the year so far against the industry’s growth of 21.9%.

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Roche’s performance in the first quarter was good on the back of the diagnostics division, which maintained its stellar performance on demand for COVID-19 tests. The pharmaceuticals business also remained stable and newer drugs continue to offset the decline in sales of legacy drugs.

However, the outlook indicated that sales will decline in 2022 year over year due to reduced demand for its COVID-19 medicines and diagnostics.

Roche currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare space are Alkermes ALKS and Geron Corporation GERN, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.

Loss estimates for GERN for 2022 have narrowed by 7 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters, the average surprise being 1.07%.




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Roche Holding AG (RHHBY) : Free Stock Analysis Report
 
Geron Corporation (GERN) : Free Stock Analysis Report
 
Alkermes plc (ALKS) : Free Stock Analysis Report
 
Seagen Inc. (SGEN) : Free Stock Analysis Report
 
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