New drug approvals - June 2024

Active Ingredient (Strength)

Trametinib dimethylsulfoxide 5.30 mg eqv trametinib(4.7 mg)

Application type

NDA-2: New presentation

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

03/06/2024

Registration No.

SIN17018P

Indications:
Unresectable or metastatic melanoma
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see section 6 Warnings and Precautions and section 12 Clinical studies).
Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 12 Clinical studies).

Adjuvant treatment of melanoma
Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with BRAF V600 mutation and involvement of lymph node(s), following complete resection.

Advanced non-small cell lung cancer
Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

Locally advanced or metastatic anaplastic thyroid cancer
Trametinib in combination with dabrafenib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options (see section 12 Clinical studies).

Low-grade glioma
Trametinib in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 12 Clinical studies).

*Evaluated as part of Project Orbis

Active Ingredient (Strength)

Dabrafenib mesylate eqv Dabrafenib(10mg)

Application type

NDA-2: New presentation

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

03/06/2024

Registration No.

SIN17019P

Indications:
Unresectable or metastatic melanoma
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see Section 12 Clinical Studies).

Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of patients with melanoma with BRAF V600 mutation, and involvement of lymph node(s), following complete resection.

Advanced non-small cell lung cancer
Dabrafenib in combination with trametinib is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation (see Section 12 Clinical Studies).

Locally advanced or metastatic anaplastic thyroid cancer
Dabrafenib in combination with trametinib is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options (see section 12 Clinical studies).

Low-grade glioma
Dabrafenib in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 12 Clinical studies).

*Evaluated as part of Project Orbis

Active Ingredient (Strength)

Atezolizumab(1875 mg/15ml)

Application type

NDA-2: New formulation

Product Registrant

ROCHE SINGAPORE PTE. LTD.

Date of Approval

27/06/2024

Registration No.

SIN17033P

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).

Metastatic non-small cell lung cancer
Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated for the treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who had not received prior chemotherapy.

Tecentriq as monotherapy is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on approved therapy for these aberrations prior to receiving Tecentriq.

Tecentriq, in combination with nab-paclitaxel and carboplatin, is indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have EGFR or ALK genomic tumor aberrations.
Tecentriq as monotherapy is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have a PD-L1 expression ≥ 50% tumor cells (TC) or ≥ 10% tumor-infiltrating immune cells (IC) and who do not have EGFR or ALK genomic tumor aberrations.

Small cell lung cancer
Tecentriq, in combination with carboplatin and etoposide, is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Triple-negative breast cancer
Tecentriq, in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors have PD-L1 expression of ≥1% on IC, and who have not received prior chemotherapy for metastatic disease.

Hepatocellular carcinoma
Tecentriq, in combination with Avastin, is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Active Ingredient (Strength)

Ravulizumab(100 mg/mL)

Application type

NDA-1: New biologcal entity

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

19/06/2024

Registration No.

SIN17026P

Indications:
Paroxysmal Nocturnal Hemoglobinuria
ULTOMIRIS is indicated for the treatment of adult and pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH)
·       who presents with clinical symptom(s) indicative of high disease activity.
·       who are clinically stable after having been treated with eculizumab for at least the past 6 months.

Atypical Hemolytic Uremic Syndrome
ULTOMIRIS is indicated for the treatment of adult and pediatric patients with atypical
hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic
microangiopathy (TMA).
Limitations of Use: ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Generalized Myasthenia Gravis
ULTOMIRIS is indicated as an add-on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Active Ingredient (Strength)

Omalizumab(75.00 mg/0.5 mL),
Omalizumab(150.00 mg/1.0 mL),
Omalizumab(300.00 mg / 2.0 mL)

Application type

NDA-2: New presentation
NDA-3: New strengths

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

21/06/2024

Registration No.

SIN17030P,
SIN17031P,
SIN17032P

Indications:
Allergic Asthma
Xolair treatment should only be considered for patients with convincing IgE mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and above)
Xolair is indicated as add-on therapy to improve asthma control in adult and adolescent (12 years of age and above) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 < 80%)as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to < 12 years of age)
Xolair is indicated as add-on therapy to improve asthma control with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Xolair is indicated as an add-on therapy to intranasal corticosteroids for the treatment of CRSwNP in adults (18 years of age and above) with inadequate response to intranasal corticosteroids.

Chronic Spontaneous Urticaria (CSU)
Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.

Active Ingredient (Strength)

Omalizumab(300.00 mg/2.0 mL)

Application type

NDA-3: New strength

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

21/06/2024

Registration No.

SIN17029P

Indications:
Allergic Asthma
Xolair treatment should only be considered for patients with convincing IgE mediated asthma (see section 4.2).

Adults and adolescents (12 years of age and above)
Xolair is indicated as add-on therapy to improve asthma control in adult and adolescent (12 years of age and above) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 < 80%)as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Children (6 to < 12 years of age)
Xolair is indicated as add-on therapy to improve asthma control with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Chronic rhinosinusitis with nasal polyps (CRSwNP)
Xolair is indicated as an add-on therapy to intranasal corticosteroids for the treatment of CRSwNP in adults (18 years of age and above) with inadequate response to intranasal corticosteroids.

Chronic Spontaneous Urticaria (CSU)
Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.