Roche launches PHESGO in India 

May 13, 2022 0 By Team FM

Swiss-biotech giant and one of the world’s leading cancer drugmakers F. Hoffmann – La Roche Ltd has launched PHESGO, its latest innovation and the first fixed dose combination (FDC) of two monoclonal antibodies – – pertuzumab (Perjeta ) and trastuzumab (Herceptin)– for easy and faster therapeutic administration against metastatic HER2-positive breast cancer, in India. 

This FDC with hyaluronidase is administered by subcutaneous injection in combination with intravenous (IV) chemotherapy. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection, reducing chair time for patients by 90 percent. PHESGO takes a few minutes for administration compared to hours with IV formulations for each round of treatment as it provides a faster, more convenient, and less invasive means to receive the therapy, according to the company.  

“Faster administration through PHESGO frees up time for everyone, including the patients, caregivers, doctors and paramedical staff. Shorter appointments helps freeing up time of HCPs to treat more patients as well,” said a company statement.    

PHESGO was first approved by the US drug regulator in June 2020 and by the European Medicines Agency (EMA) in December 2020, recognising it in the NCCN treatment guidelines. The combination injection was approved in India in October 2021 and the import licence was granted by the Drug Controller General this January. 

Explaining the clinical advantage of PHESGO, Roche said that the mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but in different locations. However,  the combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signalling pathways.

Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting. In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first line) patients with HER2-positive metastatic breast cancer.  

According to Roche medical experts who spoke to the media on the clinical efficacy of PHESGO, said that over 17000 breast cancer patients have already benefited from this innovative therapeutic approach globally as of December 2021. 

“As per our phase II ‘PHranceSCa’ study, 85 percent 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,” they said. 

“PHESGO is a pathbreaking 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,” said V Simpson Emmanuel, CEO and Managing Director, Roche Pharma India. 

Faster administration frees up time for both patients and healthcare professionals and provides cost saving benefits to healthcare systems, added Emmanuel. 

Leading medical oncologists recommend PHESGO mainly on the ground of patient convenience as well as its help to ease the healthcare system. 

“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. 

With this innovation, cancer therapy can be potentially moving from oncology wards to daycare and OPD settings, the doctors say.

According to Roche, this dual innovator FDC not only provides the best standard of care for HER2-positive breast cancer patients, but also helps save at least 20 percent therapy cost. 

With India’s insurance regulator, IRDAI, widening insurance coverage to include various modern treatment methods, immunotherapy – monoclonal antibodies given as an injection are also now covered by all insurers, said a senior commercial executive at Roche India.