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New drug indication approval - October 2022

Product Name	HIZENTRA SOLUTION FOR SUBCUTANEOUS INJECTION 200g/L
Active Ingredient	Human immunoglobulin
Product Registrant	CSL BEHRING PTE. LTD.
Date of Approval	03/10/2022
Indications: Replacement therapy in adults and children in primary immunodeficiency syndromes such as: congenital agammaglobulinaemia and hypogammaglobulinaemia common variable immunodeficiency severe combined immunodeficiency and Wiskott-Aldrich syndrome IgG subclass deficiencies with recurrent infections Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondaryhypogammaglobulinaemia and recurrent infections. Immunomodulatory therapy in adults: Hizentra is indicated for the treatment of patients with chronic inflammatorydemyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization withIVIg

Product Name	INVOKANA FILM COATED TABLET
Active Ingredient	Canagliflozin
Product Registrant	Johnson and Johnson Pte Ltd
Date of Approval	5/10/2022
Indications: to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adult patients with type 2 diabetes mellitus and diabetic nephropathy with albuminuria >300mg/day.

Product Name	DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML
Active Ingredient	Daratumumab
Product Registrant	JOHNSON & JOHNSON PTE. LTD.
Date of Approval	6/10//2015
Indications: DARZALEX® SC is indicated for the treatment of patients with multiple myeloma in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

Product Name	BRUKINSA CAPSULE 80MG
Active Ingredient	Zanubrutinib
Product Registrant	BEIGENE SINGAPORE PTE LTD
Date of Approval	10 OCT 2022
Indications: BRUKINSA as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. BRUKINSA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen.

Product Name	KISQALI 200MG FILM-COATED TABLET
Active Ingredient	Ribociclib
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	12 OCT 2022
Indications: Kisqali is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: • an aromatase inhibitor as initial endocrine-based therapy; or • fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy in postmenopausal women or in men.

Product Name	LENVIMA HARD CAPSULE 4MG AND 10MG
Active Ingredient	Lenvatinib
Product Registrant	EISAI (SINGAPORE) PTE. LTD.
Date of Approval	12 OCT 2022
Indications: Renal Cell Carcinoma (RCC) LENVIMA, in combination with pembrolizumab, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Endometrial Carcinoma (EC) LENVIMA, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation.

Product Name	TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/20 ML AND 840MG/14ML
Active Ingredient	Atezolizumab
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	13 OCT 2022
Indications: Early-stage non-small cell lung cancer Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection for adult patients with Stage II to IIIA (7th edition of the UICC/AJCC-staging system) non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and whose disease has not progressed following platinum-based adjuvant chemotherapy (see Section 3.1.2 Clinical / Efficacy Studies). *Evaluated as part of Project Orbis

Product Name	SIMPONI IV CONCENTRATE FOR SOLUTION FOR INFUSION 12.5MG/ML
Active Ingredient	Golimumab
Product Registrant	Johnson & Johnson Pte Ltd
Date of Approval	19 OCT 2022
Indications: Psoriatic Arthritis(PsA) SIMPONI® I.V. is indicated for the treatment of active psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate in patients 2 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI® I.V., in combination with methotrexate, is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have responded inadequately to previous therapy with methotrexate.

Product Name	NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100MG/ML NUCALA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100MG/ML
Active Ingredient	Mepolizumab
Product Registrant	Glaxosmithkline Pte Ltd
Date of Approval	20 OCT 2022
Indications: Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) NUCALA is indicated as add-on maintenance treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. Hypereosinophilic Syndrome (HES) NUCALA is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Product Name	VEKLURY LYOPHILIZED POWDER FOR IV INFUSION 100MG/VIAL
Active Ingredient	Remdesivir
Product Registrant	GILEAD SCIENCES SINGAPORE PTE LTD
Date of Approval	28 OCT 2022
Indication: VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults with pneumonia requiring supplemental oxygen. In clinical studies, there were no survival and recovery benefit with VEKLURY in patients under invasive mechanical ventilation (IMV), or under extracorporeal membrane oxygenation (ECMO).

Product Name	ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G
Active Ingredient	Ceftazidime pentahydrate 2g Avibactam sodium 0.5g
Product Registrant	Pfizer Private Limited
Date of Approval	05 OCT 2022
Indication: Zavicefta is indicated in adults, infants (aged 3 months and older), children, and adolescents for the treatment of the following infections (see sections 4.4 and 5.1): Complicated Intra-Abdominal Infection (cIAI) Complicated Urinary Tract Infection (cUTI), including Pyelonephritis Hospital-acquired Pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of adult patients with bacteraemia that occurs in association with, or is suspected to be associated with cIAI, cUTI, or HAP/VAP. Consideration should be given to official guidance on the appropriate use of antibacterial agents. For treatment of cIAI use in combination with metronidazole.

Product Name	KEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active Ingredient	Pembrolizumab
Product Registrant	MSD Pharma (Singapore) Pte Ltd
Date of Approval	16 OCT 2022
Indication: KEYTRUDA, as monotherapy, is indicated for the adjuvant treatment of patients with RCC at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions [see Clinical Studies (9)]. KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery. *Evaluated as part of Project Orbis

Healthcare professional, Industry member, Therapeutic Products

Published: 1 Dec 2022

New Drug Indication Approvals