New drug indication approval - Oct 2020

Product Name

PAMORELIN POWDER FOR SUSPENSION FOR INJECTION 3.75 MG PER VIAL, 11.25 MG PER VIAL, AND 22.5 MG PER VIAL

Active Ingredient

Triptorelin embonate

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

05/10/2020

Indications:

Pamorelin 3.75 mg, 11.25 mg, and 22.5 mg are indicated as concomitant to and following radiotherapy in patients with high-risk localized or locally advanced prostate cancer.

Pamorelin 3.75 mg is indicated for the treatment of endometriosis.

Pamorelin 3.75 mg is indicated for the pituitary down-regulation in the context of assisted reproduction technology.

Product Name

LENVIMA HARD CAPSULE 4MG

LENVIMA HARD CAPSULES 10 MG

Active Ingredient

Lenvatinib

Product Registrant

EISAI (SINGAPORE) PTE. LTD.

Date of Approval

09/10/2020

Indications:

LENVIMA, in combination with pembrolizumab, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior chemotherapy in the metastatic setting and are not candidates for curative surgery or radiation.

Product Name

KEYTRUDA SOLUTION FOR INFUSION 25MG/ML

Active Ingredient

Pembrolizumab

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

16/10/2020

Indications:

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior chemotherapy in the metastatic setting and are not candidates for curative surgery or radiation.