BeiGene receives approval for REVLIMID® new drug application in China

BeiGene, Ltd., a China based biopharmaceutical company, that focuses on developing and commercializing immuno-oncology and molecularly targeted drugs to treat cancer, has reportedly announced that the NMPA that is National Medical Products Administration of China has approved its supplemental new drug application for REVLIMID®, combined with rituximab, for treating patients with refractory or relapsed indolent lymphoma.

REVLIMID was first accepted in 2013 in China for treating adult patients diagnosed with multiple myeloma combined with dexamethasone and who had received one prior therapy.  Furthermore, the tag for the combination was expanded in 2018 so that adult patients suffering from newly diagnosed multiple myeloma (NDMM), who were not eligible for transplant, could be included.

REVLIMID is currently marketed by BeiGene in China, with license from Celgene Logistics Sarl, a company that works under Bristol-Myers Squibb (BMS).

Dr. Xiaobin Wu, President, BeiGene, reportedly stated that the achievement for REVLIMID marks another step in expanding the company’s hematology franchise into NHL (non-Hodgkin’s lymphoma) in China. The company, in collaboration with Amgen, will work to build a market-driven presence for the treatment of hematological cancers in China, with the pending approvals of zanubrutinib for mantle cell lymphoma and lymphocytic leukemia, tislelizumab designed for Hodgkin’s lymphoma, as well as Revlimid for multiple myeloma, and Vidaza for acute myeloid leukemia and myelodysplastic syndromes and other products.

The supplemental new drug application (sNDA) is supported by non-clinical, clinical, and CMC (chemistry, manufacturing and control) data package, together with results from the Phase 3 AUGMENT clinical study which is sponsored as well as conducted by Bristol-Myers Squibb.

The Phase 3 study is a randomized, double blind and multicenter trial where a total of 358 patients with refractory or relapsed marginal or follicular zone lymphoma were randomized 1:1 to receive REVLIMID as well as rituximab (R2) or placebo and rituximab.

R2 demonstrated improvements in PFS (progression-free survival) evaluated by an independent review committee with a median follow up of 28.3 months, comparative to the control arm with reduction of 54% in the risk of progression. The median PFS was 39.4 months for the R2 arm and 14.1 months for the control arm. A secondary point, ORR (overall response rate), was 78% in the R2 arm and 53% in the control arm.

The commonly observed adverse events (AE) in the R2 arm was 58% neutropenia and 22% in the control arm. AE that were revealed at a higher rate in the R2 arm were leukopenia, constipation, tumor flare, neutropenia, thrombocytopenia and anemia.

Source credit: http://ir.beigene.com/news-releases/news-release-details/beigene-announces-acceptance-supplemental-new-drug-application-0?loc=US