BMS Korea said that the Ministry of Food and Drug Safety has recently approved its myelofibrosis treatment Inrebic (ingredient: pedratinib) and myelodysplastic syndrome treatment Reblozyl (ingredient: ruspartercept),
Inrebic received approval from regulators to treat adults with an enlarged spleen and associated symptoms caused by primary myelofibrosis in adult patients previously treated with ruxoritinib, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
The recommended dose is 400 mg once a day, administered orally.
Unlike ruxolitinib, which inhibits Janus Kinase 1 (JAK1) and Janus Kinase 2 (JAK2) proteins in hematopoietic stem cells, Inrebic selectively acts on JAK2 to inhibit the hyperactivity of the JAK-STAT pathway. There were limitations in treatment in Korea as there were no drugs approved as a second-line treatment if Ruxolitinib treatment failed.
Reblozyl treats lowest-, low-, and moderate-risk myelodysplastic syndrome with ring sideroblasts, adult anemia patients with lowest-, low-, and moderate-risk myeloproliferative neoplasm with ring sideroblasts (MDS-RS) inadequate or unsuitable for treatment with an erythropoiesis-stimulation agent and require red blood cell transfusion, and adult patients with beta-thalassemia who require red blood cell transfusion.
Reblozyl has a mechanism of action that induces red blood cell maturation by inhibiting the over-activation of the Smad 2/3 pathway by the TGF-β superfamily ligand.
"In the MEDALIST study, Reblozyl showed a high transfusion demand reduction effect in the transfusion-dependent MDS-RS patient group," said Lee Hyung-bok, head of the company’s Anticancer Business. "As the long period of use increases the higher the clinical usefulness, the company expects it to contribute to improving the prognosis of Korean patients."
As Korea's blood stocks have plummeted due to the prolonged Covid-19 pandemic, the company expects that Reblozyl's effect on reducing blood transfusion requirements will help the country’s blood supply, Lee added.
BMS Korea CEO Kim Jin-young also said, "Starting with the approval of Onureg, an acute myeloid leukemia treatment, in March, the company has also received approval for Inrebic and Reblozyl, offering a wider range of treatment options for Korean blood cancer patients."
BMS Korea will continue to do its best to change patients' lives more healthily through innovative medicines, Kim added.
Myelodysplastic syndrome is one of the malignant diseases in the hematopoietic cells of the bone marrow. It is a geriatric disease that is rapidly increasing in the elderly over 60 years of age. The illness's characteristic includes dysplasia of blood cells in the bone marrow and decreased normal white blood cells, red blood cells, and platelets in the peripheral blood.
The most common abnormalities are symptoms such as fatigue, general weakness, and decreased exercise capacity due to anemia. If anemia is severe, symptoms such as palpitations, shortness of breath, and chest pain may also appear and develop into acute myeloid leukemia.
Myelofibrosis is a type of myeloproliferative tumor characterized by abnormal clonal proliferation of hematopoietic stem and progenitor cells.
Myelofibrosis has a poor prognosis, and hospitals decide on treatment considering the age and risk group to which the patient belongs.
Based on the 2009 International Prognostic Scoring System (IPSS), the median survival period was 11.3 years for low-risk patients, 7.9 years for intermediate-risk group-1 patients, and four years for intermediate-risk group-2 patients, and 2.3 years for high-risk patients.
Hospitals recommend allogeneic hematopoietic stem cell transplantation for patients in the intermediate-risk group-2 or high-risk group and JAK inhibitor for low-risk or intermediate-risk group-1 patients.