New drug indication approval - August 2022

Product Name

JAKAVI TABLET 5MG, 10MG, 15MG AND 20MG

Active Ingredient

Ruxolitinib

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

12/08/2022

Indications:

Acute Graft-versus-host disease

Jakavi is indicated for the treatment of patients with acute Graft versus Host Disease (aGvHD) aged 12 years and older who have inadequate response to corticosteroids.

Chronic Graft-versus-host disease

Jakavi is indicated for the treatment of patients with chronic Graft versus Host Disease (cGvHD) aged 12 years and older who have inadequate response to corticosteroids.

Product Name

VERZENIO FILM-COATED TABLET 50MG, 100MG, 150MG

Active Ingredient

Abemaciclib

Product Registrant

DKSH SINGAPORE PTE. LTD

Date of Approval

22/08/2022

Indications:

Early Breast Cancer

Abemaciclib in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor positive (HR) positive, human epidermal growth factor receptor 2 negative (HER2) negative, node-positive early breast cancer at high risk of recurrence

Advanced or Metastatic Breast Cancer

Verzenio (abemaciclib) is indicated:

• in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

• in combination with fulvestrant for the treatment of women adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Product Name

PRIVIGEN SOLUTION FOR INFUSION 100g/L

Active Ingredient

Human Immunoglobulin

Product Registrant

CSL BEHRING PTE LTD

Date of Approval

30/08/2022

Indications:

Immunomodulation in adults, and children and adolescents (0-18 years) in:

- Multifocal motor neuropathy (MMN)