First Fixed Dose Combination of Two Monoclonal Antibodies in Oncology for the Treatment of HER-2 Positive Breast Cancer

MUMBAI:
Roche Pharma today announced the India launch of PHESGO – the first ever fixed dose formulation in oncology to combine two monoclonal antibodies -Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.

PHESGO (PH-Perjeta + Herceptin; ES-Easy; GO- Go):
● Is administered as a single injection just under the skin in the thigh
● Takes a few minutes compared to hours with IV formulations for each round of treatment, thus reducing chair time for patients by 90%
● Provides a faster, more convenient, and less invasive means to receive breast cancer therapy
● Faster administration through PHESGO gives the confidence and frees up time for everyone (patients, caregivers, doctors and paramedical staff), shorter appointments, freeing up time of HCPs to treat more patients
● Frees up bed capacity faster, and provides cost saving benefits to healthcare systems

PHESGO was first approved by the USFDA in June 2020 during the peak of the Covid pandemic, by the European Medicines Agency (EMA) in December 2020, and has been recognised in the NCCN treatment guidelines. In India, PHESGO was approved by the DCGI in October 2021 and the import license was granted in January 2022. Globally, over 17000 breast cancer patients have benefitted from PHESGO as on December 2021. As per our phase II PHranceSCa study 1 , 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.

Commenting on the launch, V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India said, “PHESGO is a path breaking drug that will provide convenience and improve quality of life of patients suffering from breast cancer by significantly reducing the in- clinic time for them. Patients and their caregivers can now look forward to spending less time at the hospital and more time doing what they like most. It will also enhance the efficiency of
healthcare systems since it requires less preparation and administration time. Faster administration frees up time for both patients and healthcare professionals and provides cost saving benefits to healthcare systems. PHESGO is one more example of Roche’s commitment to our purpose of ‘Doing now what patients need next’ and pioneering efforts in the breast cancer treatment space.”

Driving access to Standard of Care
PHESGO, the Dual Innovator FDC provides the best Standard of Care for HER2+ Breast cancer patients, offering time tested efficacy at 20% lesser cost. With IRDAI widening insurance coverage to include various modern treatment methods, immunotherapy – monoclonal antibodies 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 standard of care treatment for breast cancer patients in India. Also, 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.

“Cancer treatment is very resource intensive and time consuming. Patients have to visit the hospital many times and undergo long infusion procedures. This puts a huge demand on the patient, their caregivers, and the healthcare staff at a hospital. PHESGO can significantly improve the quality of life of a patient and their caregiver while undergoing treatment and reduce the burden on the healthcare professionals, enabling them to treat more patients”, says Dr. Shona Nag, Director of Oncology, Sahyadri Group of Hospitals, Pune.