New drug indication approval - May 2024

Active Ingredient (Strength)

Dostarlimab

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

10/05/2024

Indications:

JEMPERLI is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.

*Evaluated as part of Project Orbis

Active Ingredient (Strength)

Sacituzumab govitecan(180mg/vial)

Product Registrant

GILEAD SCIENCES SINGAPORE PTE LTD

Date of Approval

24/05/2024

Indications:
TRODELVY is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

*Evaluated as part of Project Orbis

Active Ingredient (Strength)

APREMILAST (in Beige Tablet)(30 mg), APREMILAST (in Brown Tablet)(20 mg), APREMILAST (in Pink Tablet)(10 mg), Apremilast(30 mg)

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

21/05/2024

Indications:
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease who are candidates for systemic therapy.

Active Ingredient (Strength)

Abemaciclib(50mg),
Abemaciclib(150.0mg),
Abemaciclib(100.0mg)

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

28/05/2024

Indications:
1.1 Early Breast Cancer
Yulareb (abemaciclib) in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence (see section 14.1).

1.2 Advanced or Metastatic Breast Cancer
Yulareb (abemaciclib) is indicated:
• in combination with an aromatase inhibitor as initial endocrine-based therapy 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 fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Active Ingredient (Strength)

Abemaciclib(50.00mg),
Abemaciclib(100.0mg),
Abemaciclib(150.0mg)

Product Registrant

DKSH SINGAPORE PTE. LTD.

Date of Approval

28/05/2024

Indications:
Early Breast Cancer
Verzenio (abemaciclib) in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, node-positive early breast cancer at high risk of recurrence (see section 14.1).

Advanced or Metastatic Breast Cancer
Verzenio (abemaciclib) is indicated:
• in combination with an aromatase inhibitor as initial endocrine-based therapy 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 fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Active Ingredient (Strength)

CRM197 protein(Approx. 51 μg/0.5ml),Pneumococcal polysaccharide serotype 1 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 10A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 11A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 12F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 14 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 15B (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 18C (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 19A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 19F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 22F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 23F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 3 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 33F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 4 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 5 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 6A (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 6B (conjugate)(4.4 μg/0.5ml),Pneumococcal polysaccharide serotype 7F (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 8 (conjugate)(2.2 μg/0.5ml),Pneumococcal polysaccharide serotype 9V (conjugate)(2.2 μg/0.5ml)

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

16/05/2024

Indications:
Active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.