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Roche's (RHHBY) sBLA For Polivy Combo Accepted by FDA

·3-min read

Roche RHHBY announced that the FDA accepted its supplemental biologics license application (sBLA). The application seeks approval for its lymphoma drug Polivy (polatuzumab vedotin) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). A decision by the FDA is expected by Apr 2, 2023.

The sBLA for Polivy combination is based on data from the pivotal phase III POLARIX study. The Polivy-R-CHP combination exhibited a significant improvement in progression-free survival (PFS) against the current standard care of Rituxan plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC) developed by Roche using Seagen’s SGEN AFDC technology.

Seagen is entitled to receive royalties on the worldwide net sales of Polivy.

DLBCL is a type of non-Hodgkin lymphoma (“NHL”) and is aggressive in nature.

In May 2022, Roche received approval from the European Commission (EC) for using Polivy in combination with R-CHP to treat previously untreated DLBCL. The EC also converted Polivy’s conditional marketing authorization in the EU, to full approval, for the treatment of adult patients with relapsed or refractory (R/R) DLBCL, who are not candidates for a hematopoietic stem cell transplant.

Presently, Polivy is also being evaluated for the treatment of several types of NHL.

Roche shares have declined 16.9% in the year-to-date period against the industry’s return of 2.2%.

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Roche has a solid and broad oncology portfolio, and approval of additional drugs or label expansion of existing drugs will further bolster it. It has also expanded its oncology portfolio to hematology and immunology.

Recently, in July, Roche’s BLA for Lunsumio, seeking to treat adult patients with R/R follicular lymphoma (FL) who have received at least two prior systemic therapies, was accepted by the FDA.

Roche’s hematology portfolio comprises of approved drugs like MabThera/Rituxan, Gazyva, Hemlibra (for hemophilia A with factor VIII inhibitors) and Venclexta (for acute myeloid leukemia in adults), being developed in collaboration with AbbVie ABBV.

Venclexta is jointly commercialized by Genetech, a subsidiary of Roche and AbbVie in the United States and commercialized outside the states by AbbVie.

Roche performed well in the first half of 2022, driven by robust demand for its diagnostics base business and new drugs to treat hemophilia, cancer and neurological disorders.

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

Roche Holding AG Price


Roche Holding AG Price
Roche Holding AG Price

Roche Holding AG price | Roche Holding AG Quote


Zacks Rank and A Stock to Consider

Currently, Roche has a Zacks Rank #3 (Hold).

A better-ranked stock in the overall medical sector is Aerie Pharmaceuticals AERI, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Aeries’ loss estimates for 2022 have narrowed down from $2.01 per share to $1.83 over the past 30 days. Shares of AERI have returned 67.2% year to date. Earnings of Aeries miss estimates in three of the last four quarters, while beating the same in one. AERI delivered an earnings surprise of 70.27%, on average.

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