New drug approvals - October 2022

Product Name

JEMPERLI CONCENTRATE FOR SOLUTION FOR INFUSION 500MG/10ML

Active Ingredient

Dostarlimab

Application type

NDA-1: New biological entity

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

06/10/2022

Registration No.

SIN16623P

Indications:

JEMPERLI is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

Product Name

SARCLISA CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML

Active Ingredient

Isatuximab

Application type

NDA-1: New biological entity

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD

Date of Approval

17 OCT 2022

Registration No.

SIN16630P

Indications:

SARCLISA is indicated:

- in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

- in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior therapies

Product Name

Trazher (trastuzumab) Powder for Concentrate for Solution for Infusion 150mg/vial

Active Ingredient

Trastuzumab

Application type

NDA-2

Product Registrant

INNOGENE KALBIOTECH PTE. LTD.

Date of Approval

09/10/2022

Registration No.

SIN16631P

Indications:

Trazher IV

Metastatic Breast Cancer (MBC)

Trazher is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2:

a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease

b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease

c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with Trazher. This indication is based on data from one Phase III trial which studied the use of Trazher in combination with anastrozole (see Clinical/ Efficacy Studies).

Experience with other aromatase inhibitors is limited.

Early Breast Cancer (EBC)

Trazher is indicated for the treatment of patients with HER2 positive early breast cancer.

- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see Clinical/ Efficacy Studies).

- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.

- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.

- in combination with neoadjuvant chemotherapy followed by adjuvant Trazher therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see Special Warnings and Precautions for Use, and Clinical/ Efficacy Studies).

Trazher should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic Gastric Cancer (MGC)

Trazher in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Trazher should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.