Good to Know > Roche’s PHESGO for Breast Cancer Launched in India

Roche’s PHESGO for Breast Cancer Launched in India

PHESGO by Roche received its first approval from the US FDA in June 2020. The EMA also approved the formulation in the same year after which the DGCI of India nodded in October 2021. Roche got the import license later this year in January.

 

On May 12, 2022, Roche Pharma announced the launch of PHESGO (PH-Perjeta + Herceptin; ES-Easy; GO- Go) in India. It is a co-formulation of two monoclonal antibodies used in combination with chemotherapy for use: 

  • before neoadjuvant treatment (surgery) in adult patients with breast cancer that is locally advanced, HER2-positive, or node-positive provided that the tumor is larger than 2 cm. 
  • after adjuvant treatment (surgery) in adult patients with breast cancer that is HER2-positive and has a possibility of coming back.

 

PHESGO comprises pertuzumab and trastuzumab along with hyaluronidase. These two regimens are prescribed to patients with early or advanced-stage HER2-positive breast cancer in over 100 countries. The formulation is administered in combination with an IV (intravenous) chemotherapy drug. It is given subcutaneously (under the skin) as an injection. 

 

According to Roche Pharma, the new formulation can be administered to the patients in a few minutes as compared to IV injections of the same drugs. PHESGO reduces the patient’s chair time by nearly 90%. Breast cancer patients and their caretakers now need to spend very less time in the hospitals for the treatment, thanks to Roche’s drug. 

 

With the approval and launch, this medicine becomes the first-ever fixed-dose regimen that combines these two monoclonal antibodies in oncology. As of December 2021, the drug firm stated that over 17,000 patients suffering from breast cancer from all over the world received PHESGO and got benefited. Luckily, this drug can be administered to the patient at home by a healthcare professional. 

 

Roche's PHESGO got FDA (Food and Drug Administration, US) approval for the first time in June 2020. The EMA (European Medicines Agency) authorized the formulation within the next six months, while India’s DGCI (Drugs Controller General of India) gave its approval in October 2021. Roche received the import authorization in January of this year. The most common adverse effects of PHESGO include hair loss, diarrhea, low number of red and white blood cells, and lack of energy. 

 

Breast cancer that tests positive for the protein human epidermal growth factor receptor 2 is known as HER2-positive breast cancer. This protein, according to doctors and health experts, stimulates cancer cell proliferation. As per several studies, around one out of every five breast cancer cells has extra copies of the gene that produces the HER2 protein.

 

View full prescribing information of PHESGO (pertuzumab and trastuzumab).