New drug indication approval - Aug 2020

Product Name

OGIVRI 440 LYOPHILIZED POWDER FOR INJECTION

440MG

Active Ingredient

Trastuzumab

Product Registrant

MYLAN PHARMACEUTICALS PTE. LTD

Date of Approval

17/08/2020

Indications:

Ogivri™ is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC).

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

- Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section "Pharmacodynamic properties").

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

- In combination with neoadjuvant chemotherapy followed by adjuvant Ogivri™ therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see section "Warnings and Precautions" and "Pharmacodynamic properties")

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

Ogivri™ is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):

- As monotherapy for the treatment of those patients who have received at least one chemotherapy regimens for their metastatic disease.

- In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

- In combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.

This indication is based on data from one Phase III trial which studied the use of Herceptin in combination with anastrozole (see Clinical Studies). Experience with other aromatase inhibitors is limited.

Metastatic gastric cancer:

Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anticancer treatment for their metastatic disease.

Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH result, or by an IHC 3+ result. Accurate and validated assay methods should be used (see section "Warnings and Precautions" and "Pharmacodynamic properties")

Product Name

STELARA CONCENTRATE FOR SOLUTION FOR INFUSION 130MG/26ML

STELARA SOLUTION FOR INJECTION 45MG/ 0.5ML, 90MG/1ML

STELARA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 45 MG/0.5ML, 90 MG/1ML

Active Ingredient

Ustekinumab

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

17/08/2020

Indications:

STELARA® is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

Product Name

DARZALEX CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/5ML AND 400MG/20ML

Active Ingredient

Daratumumab

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

20 Aug 20

Indications:

Darzalex is indicated for the treatment of patients with multiple myeloma:

- in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant

Product Name

FOSTER NEXTHALER INHALATION POWDER 100 MCG/6 MCG PER DOSE

Active Ingredient

Beclometasone dipropionate anhydrous 100mcg per dose,  Formoterol fumarate dehydrate 6mcg per actuation

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

20 Aug 2020

Indications:

ASTHMA

Foster NEXThaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long acting beta2-agonist) is appropriate:

- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonist or

- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

Foster NEXThaler is indicated for adult patients.

COPD

Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Product Name

XTANDI™ SOFT CAPSULES 40MG

Active Ingredient

Enzalutamide

Product Registrant

ASTELLAS PHARMA SINGAPORE PTE. LTD.

Date of Approval

21 Aug 2020

Indications:

Xtandi is indicated for:

• the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).

• the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).

• the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).

• the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

Product Name

LYNPARZA (OLAPARIB) FILM-COATED TABLET 100MG

LYNPARZA (OLAPARIB) FILM-COATED TABLET 150MG

Active Ingredient

Olaparib

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

14 Aug 2020

Indications:

Adenocarcinoma of the pancreas

Lynparza is indicated as monotherapy for the:

• maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas whose disease has not progressed on a minimum of 16 weeks of first-line platinum-based chemotherapy. Germline BRCA mutation must be confirmed before LYNPARZA treatment is initiated.

Product Name

FASLODEX SOLUTOON FOR INJECTION 250MG/5ML

Active Ingredient

Fulvestrant

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

20 Aug 2020

Indications:

Combination therapy with abemaciclib

FASLODEX is indicated in combination with abemaciclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

Combination therapy with ribociclib

FASLODEX is indicated in combination with ribociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or following disease progression on endocrine therapy.