Amgen/BeiGene's Anti-Cancer Drug Carfilzomib Approved in China for Relapsed/Refractory Multiple Myeloma

Source: Yiyao Guanlan

According to the latest announcement on the website of China's National Medical Products Administration (NMPA), carfilzomib for injection (brand name: Kyprolis), co-developed by Amgen and BeOne Medicines, has been officially approved in China. BeOne Medicines is currently preparing for the commercial launch of this second-generation proteasome inhibitor for the treatment of patients with relapsed/refractory multiple myeloma (MM).

Screenshot source: Reference [1]

Intracellular proteasomes degrade damaged or unneeded proteins and play a crucial role in normal cellular function and growth. Carfilzomib, a second-generation proteasome inhibitor developed by Amgen, acts by blocking the proteasome's protein-degrading function, which leads to excessive accumulation of intracellular proteins. In certain cells, carfilzomib induces cell death. Given the high burden of abnormal proteins in myeloma cells, carfilzomib's effect in triggering myeloma cell death is particularly pronounced.

In 2016, carfilzomib was approved by the U.S. FDA as a monotherapy or in combination with dexamethasone or dexamethasone plus lenalidomide for the treatment of patients with relapsed or refractory multiple myeloma (MM). It has also been approved for marketing in countries and regions including Australia, Canada, Hong Kong (China), Japan, South Korea, Switzerland, and Russia.

In the phase 3 ASPIRE clinical trial, 792 patients with relapsed or refractory MM received treatment with either carfilzomib in combination with lenalidomide and dexamethasone (KRd) or lenalidomide and dexamethasone (Rd). These patients had previously received 1 to 3 other therapies.

The trial results showed that the median overall survival (OS) was 48.3 months in the KRd treatment group compared with 40.4 months in the Rd treatment group. KRd therapy extended OS by 7.9 months. In the subgroup of patients who had received only one prior line of therapy, KRd demonstrated superior efficacy, extending median OS by 11.4 months compared with Rd therapy. Progression-free survival (PFS) data for the patients were published last year, showing that KRd extended PFS by 8.7 months compared with Rd therapy. (Original text abridged)

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