New drug indication approval - July 2023

Product Name

KEYTRUDA SOLUTION FOR INFUSION 25MG/ML

Active Ingredient

Pembrolizumab

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

14/07/2023

Indications:

KEYTRUDA, as monotherapy, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adults patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

 

Product Name

OPDIVO 10 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active Ingredient

Nivolumab

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

19/07/2023

Indications:

OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.

OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥1%.

*Evaluated as part of Project Orbis

 

Product Name

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 MG/2 ML

DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 MG/1.14 ML

Active Ingredient

Dupilumab

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE LTD

Date of Approval

26/07/2023

Indications:

DUPIXENT is indicated for the treatment of adults and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

DUPIXENT can be used with or without topical corticosteroids.

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals