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07-07-2017 | FDA | News


Rituximab–hyaluronidase human combination approved for multiple indications

medwireNews: The FDA has granted regular approval for combined use of subcutaneous rituximab and hyaluronidase human for follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

The treatment may be given as a first-line therapy alongside CHOP or other anthracycline-based regimens for patients with DLBCL, and to CLL patients as a first- or later-line treatment in combination with fludarabine and cyclophosphamide.

In addition, the combination is approved in several FL indications, including as a single agent for relapsed or refractory disease, as a first-line therapy given alongside chemotherapy, or as a single-agent maintenance agent after patients have responded to rituximab plus chemotherapy. Patients with stable FL may also be given the combination after first-line chemotherapy.

The subcutaneous formulation avoids the need for intravenous rituximab infusion, shortening treatment time from several hours to around 7 minutes and allowing use of a flat dose of rituximab 1400 mg plus hyaluronidase human 23,400 U for patients with FL or DLBCL, and rituximab 1600 mg plus hyaluronidase human 26,800 U for CLL.

The approval is based on data from the SABRINA, MabEase, and SAWYER trials which showed the combination to have non-inferior rituximab trough concentrations compared with intravenous delivery, as well as comparable efficacy and safety.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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