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BeiGene says cancer therapy gets nod for review for additional use in China

BeiGene Ltd. said China's National Medical Products Administration accepted the application to review Revlimid, combined with Rituxan, for treating a type of blood cancer.

The Beijing-based drugmaker said the NMPA accepted the supplemental new drug application for the combination for treating patients with relapsed or refractory indolent lymphoma, especially follicular lymphoma and marginal zone lymphoma.

Follicular lymphoma is a cancer of a certain type of white blood cells, B lymphocytes. Normally, these cells protect the body against bacteria or viruses, but in patients with follicular lymphoma, the defective white blood cells form tumors in organs, bone marrow and lymph nodes. Marginal zone lymphomas are those that develop at the edge of the lymphoid tissue where B lymphocytes are located.

Revlimid is owned by Bristol-Myers Squibb Co.'s Celgene Corp., while Rituxan is owned by Roche Holding AG. Bristol-Myers acquired Revlimid through the $95 billion acquisition of Celgene, which closed in late November.

BeiGene markets Revlimid in China under an exclusive deal with Celgene.

The application is supported by results from a late-stage study of the combination therapy in 358 patients with relapsed or refractory follicular or marginal zone lymphoma. Under the phase 3 trial, called Augment, the combination was shown to significantly extend the lives of patients without the disease getting worse.

Revlimid was already approved in China in 2013 in combination with dexamethasone for treating multiple myeloma, another type of blood cancer, in adults who have received at least one prior therapy. In 2018, the label for the combination was expanded to include adult patients with newly-diagnosed multiple myeloma who are not eligible for transplant.

Revlimid is approved in different countries for a variety of blood cancer indications.