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Roche's Subcutaneous Formulation of MabThera Gets EU Nod

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Roche Holding AG (RHHBY - Free Report) announced that the European Commission (EC) has approved the subcutaneous (SC) formulation of MabThera (rituximab) for the treatment of patients suffering from previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL). The approved dose for this indication is 1600 mg.

The subcutaneous (SC) formulation of MabThera is intended to save time and ease treatment burden over the intravenous form.

The approval was based on positive results from the phase Ib study, SAWYER, which demonstrated comparable safety and efficacy of the two formulations, both in combination with chemotherapy.

We note that MabThera is approved for the treatment of several types of blood cancers – certain forms of non-Hodgkin lymphoma (NHL) and CLL.

In the U.S., Roche markets MabThera as Rituxan, in collaboration with Biogen (BIIB - Free Report) .

Approval of the SC formulation of MabThera will broaden Roche’s hematology portfolio, which currently comprises approved drugs like MabThera/Rituxan, Gazyva/Gazyvaro, Tecentriq (atezolizumab) and Venclexta, and has an encouraging pipeline including investigational candidates like polatuzumab vedotin/RG7596 and a small-molecule antagonist of MDM2 (idasanutlin/RG7388).

Last month, the FDA granted accelerated approval to Tecentriq for the treatment of patients suffering from locally advanced or metastatic urothelial carcinoma, who experienced disease progression during or after platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.

Moreover, Roche is developing emicizumab (ACE910) for the treatment of hemophilia A.

We expect investors to focus on new drug approvals at Roche, as the company’s top line could be marred by the entry of biosimilars for its key drugs (expected in the second half of 2017 in Europe) like MabThera and Herceptin.

Roche currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Pfizer Inc. (PFE - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).

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