CDSCO Panel Clears Bristol Myers' Yervoy for Two New Cancer Indications
New Delhi: In a significant regulatory development for cancer care in India, the Subject Expert Committee functioning under the Central Drugs Standard Control Organization (CDSCO) has recommended approval for two additional indications of Ipilimumab 5 mg/mL concentrate for solution for infusion (50 mg), marketed as Yervoi by Bristol Myers Squibb India.
This came after the firm presented a proposal for grant of approval of the following additional indications of Ipilimumab 5 mg/mL concentrate for solution for infusion (50mg/10mL).
- Hepatocellular Carcinoma:- Ipilimumab, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
- Melanoma:- Ipilimumab in combination with Nivolumab is indicated for the treatment of unresectable or metastatic melanoma in adult patients.
Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibody used to treat metastatic or unresectable melanoma. Ipilimumab is a fully humanized IgG1 monoclonal antibody that blocks cytotoxic T lymphocyte antigen-4 (CTLA-4). Blocking CTLA-4 removes an inhibitory signal from reducing the activity of T lymphocytes. Ipilimumab was developed by Bristol-Myers Squibb and Medarex.
Ipilimumab was granted FDA approval on 25 March 2011.
Cytotoxic T-lymphocyte antigen-4 (CTLA-4) is an inhibitory molecule that competes with the stimulatory CD28 for binding to B7 on antigen-presenting cells. CTLA-4 and CD28 are both presented on the surface of T-cells.Ipilimumab is a human IgG1 that binds CTLA-4, preventing the inhibition of T-cell-mediated immune responses to tumors.
At the recent SEC meeting for oncology, the expert panel reviewed the proposal for grant of approval of the additional indications of Ipilimumab 5 mg/mL concentrate for solution for infusion (50 mg/10 mL).
The committee noted that the proposed indication with respect to Hepatocellular Carcinoma is approved in 43 countries, including the US, EU, UK, Canada, Japan, Australia and Switzerland. Similarly the proposed indication with respect to Melanoma is approved in 76 countries, including the United States, the EU, Australia, Canada, Japan and Switzerland.
After detailed deliberation, the committee recommended for the grant of approval for the proposed additional indications.
