New drug indication approval - April 2023

Product Name

ACTEMRA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML

Active Ingredient

Tocilizumab

Product Registrant

ROCHE SINGAPORE PTE LTD

Date of Approval

04/04/2023

Indications:

Tocilizumab is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

Product Name

ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG

Active Ingredient

Trastuzumab derutuxtecan

Product Registrant

Astrazeneca Singapore Pte Ltd

Date of Approval

25/4/2023

Indications:

HER2-Low

ENHERTU as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.

*Evaluated as part of Project Orbis