Singapore  : Novartis announced today, the launch of Jakavi, the first and only approved oral medication to treat patients suffering from myelofibrosis in Singapore, and across more than 50 countries. Jakavi(R) (INC 424, ruxolitinib) is a JAK 1 and JAK 2 inhibitor for the treatment of disease-related splenomegaly and/or symptoms in adult patients with myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

Myelofibrosis is an uncommon and a particular type of life-threatening blood cancer (myeloid neoplasm) characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms, severely impacting people’s quality of life. In Singapore, Myeloid Neoplasms, a group of blood cancers, constitute one of the top 10 cancers in males across all ethnic groups as well as in females of Malay and of Indian ethnicity. Studies show that patients with myelofibrosis have a median overall survival of less than 6 years and traditionally, prognosis of this condition is poor and treatment options are limited. Patients suffer symptoms arising from insufficient numbers of normal blood cells and chronic inflammation. These include but are not limited to extreme fatigue, night sweats and intractable pruritus (itching), poor quality of life and weight loss, as well as fatality[1].

“The approval of Jakavi(R) by the Health Sciences Authority brings an urgently needed new treatment option to patients with myelofibrosis,” said Dr. Grace Kam, Hematologist at Singapore General Hospital. “By targeting the JAK-STAT pathway which is dysregulated in myelofibrosis, Jakavi(R) delivers a rapid and durable benefit that has the potential to make a real difference in the lives of patients with myelofibrosis.”

“Beyond patients residing in Singapore, the availability of Jakavi(R) – currently the only treatment to myelofibrosis – in Singapore would also benefit patients from some countries in South East Asia, where Jakavi(R) is currently unavailable and stem cell transplant may not be feasible,” said Dr. Daryl Tan, Specialist in Haematology & Consultant at Raffles Cancer Centre. The launch of Jakavi(R) reinforces Singapore’s reputation as a medical hub in addition to its internationally accredited healthcare providers and modern approach to medicine in the region.

“Jakavi(R) will address the unmet treatment needs for myelofibrosis patients in Singapore,” said Parames Suwansiri, Business Unit Head, Oncology, Novartis Singapore. “We are committed to the development of innovative treatments for orphan diseases, and are furthering research to assess the potential of targeting Jakavi therapy for other malignancies associated with a dysregulated JAK pathway.”

A pooled overall survival analysis of the ongoing Controlled Myelofibrosis Study with Oral JAK Inhibitor Therapy (COMFORT-I and -II) studies showed risk of death at three years was reduced by 35% in patients initially randomized to treatment with Jakavi(R) compared to those randomized to the placebo group. Among all patients in the study, bigger spleen size before treatment was associated with higher risk of death. In analysing the impact of disease mutations on spleen size reduction, anemia development and overall survival in patients with myelofibrosis initially randomized to treatment showed Jakavi had a similar effect in patients with certain disease mutations as well as for patients without these mutations.

A two-year Controlled Myelofibrosis Study with Oral JAK Inhibitor Therapy showed patients who are on the Jakavi(R) treatment has also resulted in sustained reductions in spleen size, a hallmark of myelofibrosis, while also improving quality of life and extending overall survival compared to placebo or the best available therapy (BAT).

Jakavi is now available in Singapore and approved by the Health Sciences Authority Singapore.

Source : ACN Newswire