New drug approvals - November 2023

Product Name

ADRENALINE AGUETTANT SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 0.1 MG/ML

Active Ingredient (Strength)

Adrenaline tartrate equivalent to adrenaline (0.1 mg/ml)

Application type

NDA-2: New formulation / strength

Product Registrant

AGUETTANT ASIA PACIFIC PTE. LTD.

Date of Approval

07/11/2023

Registration No.

SIN16897P

Indications:

Cardiopulmonary resuscitation
Acute anaphylaxis in adults

Product Name

AKYNZEO® IV CONCENTRATE FOR SOLUTION FOR INFUSION 235 MG/0.25 MG/VIAL

Active Ingredient (Strength)

Fosnetupitant Chloride Hydrochloride equivalent to Fosnetupitant (235mg/vial), Palonosetron hydrochloride equivalent to Palonosetron (0.25 mg/vial)

Application type

NDA-1: New chemical entity

Product Registrant

JUNIPER BIOLOGICS PTE LTD

Date of Approval

28/11/2023

Registration No.

SIN16899P

Indications:

AKYNZEO IV is indicated in adults for the:
- Prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin.
- Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Product Name

LOCAMETZ 25 MICROGRAMS, KIT FOR RADIOPHARMACEUTICAL PREPARATION OF GALLIUM (68GA) GOZETOTIDE SOLUTION

Active Ingredient (Strength)

Gozetotide (25μg/vial)

Application type

NDA-1: New chemical entity

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

30/11/2023

Registration No.

SIN16904P

Indications:

Locametz, after radiolabelling with gallium-68, is indicated for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:

· Primary staging of patients with high-risk PCa prior to primary curative therapy,

· Suspected PCa recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy,

· Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

*Evaluated as part of Project Orbis

Product Name

TRAZHER (TRASTUZUMAB) POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 420MG/VIAL

Active Ingredient (Strength)

Trastuzumab (420 mg/vial)

Application type

NDA-3: New pack size

Product Registrant

INNOGENE KALBIOTECH PTE. LTD.

Date of Approval

22/11/2023

Registration No.

SIN16898P

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.