Summary
BeOne Medicines Ltd. (ONC) announced a significant regulatory milestone as the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID® (lenalidomide) in combination with rituximab. This application seeks approval for the treatment of patients suffering from relapsed or refractory indolent lymphoma, specifically follicular lymphoma or marginal zone lymphoma. This represents a potential expansion of REVLIMID's therapeutic indications in China beyond its current approvals for multiple myeloma.
Key Highlights
- 1NMPA acceptance of sNDA for REVLIMID in combination with rituximab for relapsed/refractory indolent lymphoma (follicular lymphoma, marginal zone lymphoma).
- 2This sNDA aims to expand REVLIMID's approved indications in China.
- 3REVLIMID is already approved in China for multiple myeloma (since 2013) with label expansions in 2018.
- 4The drug is marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl (a Bristol-Myers Squibb company).
- 5This development signals potential new revenue streams and market opportunities for BeiGene in the Chinese oncology market.
- 6The filing includes the full press release announcing this regulatory update as an exhibit.
Frequently Asked Questions
The acceptance of the supplemental new drug application (sNDA) by the China National Medical Products Administration (NMPA) is a crucial step towards potentially gaining approval for REVLIMID in combination with rituximab for a new indication: treating relapsed or refractory indolent lymphoma. This could expand the drug's market reach and revenue potential in China.
The sNDA specifically covers the treatment of patients with relapsed or refractory indolent lymphoma, including follicular lymphoma and marginal zone lymphoma.
Currently, REVLIMID is approved in China for the treatment of multiple myeloma. It was first approved in 2013 in combination with dexamethasone for adult patients who have received at least one prior therapy, and its label was expanded in 2018 to include adult patients with newly-diagnosed multiple myeloma not eligible for transplant.
REVLIMID is marketed in China by BeiGene, Ltd. under an exclusive license agreement with Celgene Logistics Sarl, which is a Bristol-Myers Squibb company.