Amgen has received expanded approval from the US Food and Drug Administration (FDA) for Kyprolis (carfilzomib) combination regimen to include in the treatment of multiple myeloma.
The drug, in combination with Darzalex Faspro and dexamethasone, was indicated for adults with relapsed or refractory (R/R) multiple myeloma, who received one to three lines of therapy.
Kyprolis is an anti-cancer medication that works by blocking proteasomes, resulting in an excessive build-up of proteins in myeloma cells, which contain excessive abnormal proteins.
It was already approved in the US, as a monotherapy, and in combination with dexamethasone, or lenalidomide plus dexamethasone, or with daratumumab and dexamethasone to treat R/R multiple myeloma.
In 2019, the biopharmaceutical company has partnered with BeiGene to commercialise its drugs Xgeva, Kyprolis and Blincyto in China, for five or seven years.
Earlier this year, BeiGene has received the China National Medical Products Administration (NMPA) approval for Kyprolis plus dexamethasone to treat R/R multiple myeloma.
Amgen R&D executive vice president David Reese said: “I am pleased that the addition of subcutaneous daratumumab to KYPROLIS plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden.”
The expanded FDA approval was supported by the ongoing Phase 2 PLEIADES trial in 66 patients with R/R multiple myeloma.
The study is designed to evaluate Darzalex Faspro, in combination with four standard-of-care treatment regimens in multiple myeloma patients.
According to updated data, Kyprolis plus Darzalex Faspro and dexamethasone showed similar response rates to those in the Phase 3 CANDOR study.
The ongoing Phase 2 trial showed an overall response rate of 84.8% with Darzalex Faspro-Kd, which is the primary endpoint of the study.
In a separate development, Amgen has released positive top-line results from the Phase 3 DISCREET Study of Otezla (apremilast) in treating genital psoriasis.
The study showed that Otezla as 30mg twice daily oral treatment has achieved a clinically meaningful and statistically significant improvement, compared to placebo.
It has met the primary endpoint of modified static Physician’s Global Assessment of Genitalia (sPGA-G) response at week 16.
Also, all secondary endpoints were met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response, at week 16.
Reese added: “Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease.
“Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies.
“The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis.”
