New drug indication approval - Feb 2022

Product Name

DARZALEX SC SOLUTION FOR INJECTION

Active Ingredient

Daratumumab

Product Registrant

JOHNSON & JOHNSON PTE LTD

Date of Approval

04/02/2022

Indications:

DARZALEX® SC in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of newly diagnosed patients with light chain (AL) amyloidosis.

KEYTRUDA SOLUTION FOR INFUSION 25 MG/ML

Active Ingredient

Pembrolizumab

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

04/02/2022

Indications:

Keytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of patients with locally advanced or metastatic carcinoma of the esophagus or HER2 negative gastroesophageal junction (GEJ) adenocarcinoma (tumors with epicenter 1 to 5 centimeters above the GEJ) that is not amenable to surgical resection or definitive chemoradiation.

Product Name

OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML

Active Ingredient

Nivolumab

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Date of Approval

16/02/2022

Indications:

OPDIVO, in combination with fluoropyrimidine- and platinum-based chemotherapy, is indicated for the treatment of patients with unresectable HER2 negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or oesophageal adenocarcinoma (see section 5.1).

*Evaluated as part of Project Orbis

Product Name

XARELTO FILM-COATED TABLET 15MG AND 20MG

Active Ingredient

Rivaroxaban

Product Registrant

BAYER (SOUTH EAST ASIA) PTE. LTD.

Date of Approval

21/02/2022

Indications:

Paediatric population

Xarelto 15 mg

Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Xarelto 20 mg

Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.