Roche's (RHHBY) Combination Cancer Remedy Wins FDA Approval

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RocheRHHBY announced that the FDA has granted approval to the subcutaneous injection of its marketed lymphoma drug MabThera/Rituxan as Rituxan Hycela for the treatment of adults with different types of blood cancers.

The injection used Halozyme Therapeutics' HALO proprietary Hycela (hyaluronidase), an FDA-approved enzyme that facilitates the delivery of a large volume of medicine under the skin.

Note that, MabThera/Rituxan is already approved in the U.S. for healing relapsed indolent non-Hodgkin Lymphoma (NHL). It is also sanctioned in the EU for treating patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL). Note that MabThera is traded by its brand name Rituxan in the U.S., Japan and Canada.

The approval was based on three phase III clinical studies and one phase Ib study in different types of blood cancers. The studies demonstrated that the combination of Rituxan and Hycela, resulted in non-inferior levels of rituximab in the blood and showed positive clinical efficacy outcomes compared with the intravenous Rituxan alone.

One of the studies also showed that 77% of patients preferred the combination therapy over Rituxan as treatment with Rituxan-Hycela can be administered in just five to seven minutes compared with the prolonged procedure of 1.5 hours under the influence of intravenous Rituxan.

Notably, Rituxan-Hycela received an FDA approval for treating three most common types of blood cancers, including follicular lymphoma, diffuse large B-Cell lymphoma (DLBCL) and chronic lymphocytic leukaemia (CLL).

Per the company's press release, approximately 198,000 patients worldwide are estimated to be annually diagnosed with the two types of above-mentioned lymphoma. Leukaemias are estimated to affect around 3.5 million people each year globally. Hence, patients suffering from the above mentioned blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan. Moreover, it can be administered in lesser time compared to IV infusion.

We remind investors that competition from Amgen AMGN and Novartis NVS biosimilars loom large on Rituxan. However, the biosimilar versions of Rituxan are expected to enter Europe in the second half of 2017.

In a separate press release, the company has announced presentation of results from a new post-hoc phase III study evaluating its marketed drug Ocrevus (ocrelizumab) at the European Academy of Neurology (EAN). Ocrevus is indicated for treating patients with relapsing and primary progressive forms of multiple sclerosis.

The post-hoc analyses revealed that Ocrevus has increased disease control in patients with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). A higher proportion of RMS patients (75%) achieved No Evidence of Disease Activity (NEDA) when applied with Ocrevus compared with the interferon beta-1a (Rebif) arm. Also a higher proportion of PPMS patients (47%) achieved No Evidence of Progression (NEP) with Ocrevus compared with placebo.

Notably in Mar 2017, Ocrevus had passed the FDA approval test for treatment of both RMS and PPMS.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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