Roche’s Atezolizumab receives DCGI approval for treatment of metastatic triple-negative breast cancer in India

Roche India announced the launch of Atezolizumab for the treatment of metastatic triple-negative breast cancer (TNBC) in India.

Atezolizumab (cancer immunotherapy drug) in combination with nab-Paclitaxel (Chemotherapy) can now be used as a first-line treatment for TNBC patients. This approval from the Drug Controller General of India (DCGI) is based on the data from phase III IMpassion130 study according to which Atezolizumab is proven to significantly reduce the risk of disease worsening or death (PFS) in the intention-to-treat and PD-L1 positive population with metastatic or unresectable locally advanced triple-negative breast cancer (TNBC). Additionally, it has shown an encouraging overall survival (OS) in the PD-L1 positive population at this interim analysis.

“Atezolizumab is the first immunotherapy drug to be approved globally and in India for triple negative breast cancer, an aggressive disease with very limited treatment options,” said V Simpson Emmanuel, General Manager, Roche Products. “Roche has been at the forefront of improving the lives of patients diagnosed with breast cancer. This launch further strengthens our commitment to provide better outcomes for patients with unresectable locally advanced and metastatic triple-negative breast cancer in India.”

Breast cancer is the most common cancer amongst women across the world impacting 2.1 million women each year. (1) According to Globocan 2018, over 160,000 new cases of breast cancer were in India. (2) TNBC is a rare type of breast cancer that experiences rapid progression and it is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. (3) Triple negative breast cancer represents 31% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. (4)

Reference:

1. https://www.who.int/cancer/prevention/diagnosis-screening/breast-cancer/en/

2. Globocan 2018 – https://gco.iarc.fr/today/data/factsheets/populations/356-india-fact-sheets.pdf

3. Pal SK et al. Triple negative breast cancer: unmet medical needs. Breast Cancer Res Treat. 2011;125(3):627–636. – https://www.ncbi.nlm.nih.gov/pubmed/21161370

4. GS Sandhu et al. Prevalence of Triple-Negative Breast Cancer in India: Systematic Review and Meta-Analysis J Glob Oncol. 2016 Dec; 2(6): 412–421 – https://www.ncbi.nlm.nih.gov/pubmed/28717728