New Drug Indication Approval - Feb 2020

 

Product Name

NIVOLUMAB BMS CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML

Active Ingredient

Nivolumab

Product Registrant

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD

Date of Approval

03/02/2020

Indications: 

Melanoma

Nivolumab as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1).

Non-Small Cell Lung Cancer (NSCLC)

Nivolumab as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)

Nivolumab as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

Classical Hodgkin Lymphoma (cHL)

Nivolumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin (see section 5.1).

Squamous Cell Cancer of the Head and Neck (SCCHN)

Nivolumab as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy (see section 5.1).

 

Product Name

IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/ML

Active Ingredient

Durvalumab

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

28/02/2020

Indications: IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

 

Product Name

VENCLEXTA FILM-COATED TABLET 10 MG, 50 MG AND 100 MG

Active Ingredient

Venetoclax

Product Registrant

ABBVIE PTE LTD

Date of Approval

11/02/2020

Indications: VENCLEXTA is indicated, in combination with obinutuzumab, for the treatment of patients with previously untreated CLL.


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals

4 Mar 2020