INDIA – Swiss multinational Roche Pharma has announced the launch of PHESGO, the world’s first fixed dose combination of two monoclonal antibodies in oncology for the treatment of HER-2 positive breast cancer, in India.
This is the first time the company has combined Perjeta (pertuzumab) and Herceptin (trastuzumab) injections that can be administered through the skin (subcutaneous administration).
According to the company, it can be used in conjunction with intravenous (IV) chemotherapy to treat early and metastatic HER2-positive breast cancer.
It is also the world’s first subcutaneous therapy for the treatment of early and metastatic HER2-positive breast cancer, providing faster and more comfortable administration of the two monoclonal antibodies under the skin in minutes rather than hours with standard intravenous administration
The Roche Pharma phase II PHranceSCa study found that 85% of people receiving treatment for HER2-positive breast cancer preferred PHESGO over IV administration due to less time in the clinic and more comfortable treatment administration.
The combination of the two medications is a standard treatment regimen approved in over 100 countries for both early and advanced HER2-positive breast cancer.
PHESGO will be at least 20% less expensive than administering the medications separately. It will also make patients’ lives easier and improve their quality of life.
While trastuzumab (Herceptin) is no longer on the market and has several generic (biosimilar) competitors, pertuzumab (Perjeta) is still a patented product worldwide.
In India, the maximum retail price of PHESGO’s maintenance dose is 2.8lakh (US$3,621). However, Roche claims that its Blue Tree Patient Assistance Program has several patient assistance programs to make the medicine more accessible.
The Insurance Regulatory and Development Authority’s (IRDAI) recent decision to broaden insurance coverage to include various modern treatment methods, such as immunotherapy (monoclonal antibodies given as an injection), will also drive affordability among insured patients.
PHESGO was approved by the US Food and Drug Administration (FDA) in June 2020, at the height of the Covid-19 pandemic, and by the European Medicines Agency (EMA) in December 2020, and it is now included in the NCCN (National Comprehensive Cancer Network) treatment guidelines.
In India, the Drugs Controller (DCGI) approved PHESGO in October 2021, and the import license was granted in January 2022.
As of December 2021, over 17000 breast cancer patients had benefited from PHESGO globally, the company said.