Takeda Pharmaceuticals Korea한국다케다제약 said its Ninlarco (ingredient name: ixazomib) had received permission from the Ministry of Food and Drug Safety식품의약품안전처 to administer a combination therapy with Lenalidomide and Dexamethasone, in treating patients with multiple myeloma.
Multiple myeloma is a disease caused by a type of immune cells called plasma cells. Even though it is a blood disease, its main symptoms are fractures and osteoporosis. The number of multiple myeloma varies by race and region, with an average of 5.6 per 100,000 in the West and 1-3 in Asia, with a lower incidence in the Asian region. According to Statistics Korea, the number of patients with multiple myeloma in Korea was 1,396 as of 2014.
Ninlarco is the first oral protease inhibitor shown to be effective in patients with relapsed or refractory multiple myeloma and reversibly binds, and was designated as a rare drug by the ministry in May 2016.
"Ninlarco's domestic license is another example of Takeda's continued efforts and investment to develop innovative new medicines for patients," said Mahender Nayak, Takeda Pharmaceuticals Korea’s general manager. "As the first oral protease inhibitor, Ninlarco is expected to improve the progression-free survival of patients with multiple myeloma significantly, as well as improve the patients’ quality of life by increasing the convenience of medication.”
Ninlarco is administered orally at the recommended starting dose of 4 mg on days 1, 8, and 15 of the 28-day cycle. Lenalidomide is recommended to start at 25 mg and is given orally once daily from day 1 to day 21 of the 28-day cycle. The recommended starting dose of Dexamethasone is 40 mg orally once a week on days 1, 8, 15, and 22 of the 28-day cycle.
Their marketing authorization is based on the results of a randomized, double-blind, phase 3 study (TOURMALINE-MM1 study) on 722 patients with relapsed or refractory multiple myeloma.
The duration of progression-free survival (PFS) was extended by approximately six months (median) compared to the combination of “Ninlarco+ Lenalidomide+ Dexamethasone” in combination with “placebo (no active therapeutic effect) + Lenalidomide+ Dexamethasone.” The median follow-up period was 23 months, but both groups have yet to reach the median overall survival rate (OS) yet.
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