Roche launches PHESGO for HER-2 positive breast cancer treatment in India

In June 2020, USFDA first approved PHESGO and in the same year, the European Medicines Agency (EMA) had also approved the formulation. In India, the Drugs Controller General of India (DGCI) approved PHESGO in October last year and the import license was granted in January this year.

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PHESGO is composed of two monoclonal antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab). (

Roche Pharma on Thursday announced the India launch of PHESGO which is the world’s first-ever fixed-dose formulation in the history of cancer treatment to combine two monoclonal antibodies. The formulation is composed of antibodies Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, which is administered under the skin via injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. According to the Pharma major, this is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.

According to Roche, PHESGO is administered as a single injection just under the skin on the thigh and it takes a few minutes compared to hours with IV formulations for each round of treatment and it reduces the chair time for patients by 90 percent.

“PHESGO provides the best set of care for HER2-positive breast cancer. It costs 20 percent less than what a patient would have paid if they purchase two products separately. This is a great advantage. PHESGO will also be supported through the blue tree programme. The patients will have holistic benefits and value-added services which come as a part of our blue tree services. We are also working very closely with central government agencies and other insurance segments to make sure that this breakthrough drug is available and accessible to a wider section of patients,” V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India told Financial

During the press conference, Emmanuel explained that PHESGO provides a faster, more convenient, and less invasive means to receive breast cancer therapy. He also said that it will also enhance the efficiency of healthcare systems since it requires less preparation and administration time.

“Faster administration through PHESGO gives the confidence and frees up time for patients, caregivers, doctors, and paramedical staff, shorter appointments, freeing up the time of Health care professionals to treat more patients. It also frees up bed capacity faster and provides cost-saving benefits to healthcare systems,” the panelists stated during the press conference on Thursday.

In June 2020, USFDA first approved PHESGO and in the same year the European Medicines Agency (EMA) approved it in December. In India, the Drug Controller General of India (DGCI) approved PHESGO in October last year and the import license was granted in January this year. Some of the side-effects of Phesgo when given with chemotherapy to treat early-stage HER2-positive breast cancer are: Hair loss, nausea, diarrhea, low red blood cell levels and weakness.

The company stated that over 17,000 breast cancer patients have benefitted from PHESGO as of December 2021 around the world. “As per our phase II PHranceSCa study1, 85% of people receiving treatment for HER2-positive breast cancer preferred treatment with PHESGO compared to IV administration due to less time in the clinic and more comfortable treatment administration,” the company stated in its press release.

“When the drugs are given through IV, a large quantity of liquid goes into at a very slow speed and takes a lot of time. With PHESGO which is injected directly under the skin, the pressure is higher. The needle is just inserted into the skin and pressed slowly, wait for 5-8 minutes and that’s it. You remove the syringe and the patient is kept under observation for 15 minutes for the follow-up injection and it’s done. With this method, the drug enters the body in a much faster way,” Bruno Jolain, Chief Medical Director, Roche India told Financial

During the press conference, Emmanuel also informed that with IRDAI widening insurance coverage to include various modern treatment methods, immunotherapy – monoclonal antibodies are given as an injection are now covered by all insurers. This, along with support through Roche’s Patient Assistance Program will help significantly drive access to the standard of care treatment for breast cancer patients in India.

“During the Covid pandemic, cancer patients were significantly impacted due to delayed treatment interventions. PHESGO can help breast cancer patients continue receiving their treatment due to significantly shorter administration times and convenience of subcutaneous administration, potentially moving the treatment from oncology wards to daycare and OPD settings,” Emmanuel said during the press conference.

HER2-positive breast cancer is a type of breast cancer in which the patient tests positive for a protein called human epidermal growth factor receptor 2 (HER2). According to doctors and health experts, this protein promotes the growth of cancer cells. Several studies suggest that in about 1 of every 5 breast cancers, the cancer cells have extra copies of the gene that makes the HER2 protein.

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