Perjeta and Herceptin combination drug, Phesgo

First challenge for improved anti-cancer drug Biobetter

Significantly improved convenience with subcutaneous injection formulation

Phesgo, a subcutaneous injection-type combination of Perjeta and Herceptin, challenges insurance coverage registration.

 

As a result of the coverage, Phesgo of Roche Korea is presented to the Cancer Disease Review Committee of the HIRA today (30th).

 

This is the first case of an improved anti-cancer biobetter.

 

Biobetter refers to drugs recognized by the Minister of the Ministry of Food and Drug Safety as having improved safety, effectiveness, and usefulness (medical compliance, convenience, etc.) compared to previously approved biological drugs, or as being progressive in pharmaceutical technology.

 

In the case of Phesgo, by replacing Herceptin and Perjeta, which were used for intravenous injections, with fixed-dose subcutaneous injections, it was recognized for its innovativeness in improving patient convenience and reducing treatment time and was named as the first improved biologic drug for anticancer drugs.

 

For example, if a patient with metastatic HER2-positive breast cancer who was receiving maintenance therapy every 3 weeks with Herceptin·Perjeta intravenous injection changes the therapy to Phesgo SC, the total time required for dosing and monitoring is 20 minutes from 270 minutes (90 minutes + 180 minutes).

 

(5 minutes + 15 minutes), it is reduced by more than 90% compared to before.

 

In addition, Pesco is a subcutaneous injection administered into the thigh rather than into a vein and can reduce blood vessels and nerve damage caused by repeated intravenous injection.

 

In Korea, Phesgo was approved by the Ministry of Food and Drug Safety for the same indication as Perjeta, so it is expected that the subject of reimbursement will also be discussed according to Perjeta standards.

 

The NCCN Guidelines state that Phesgo can replace Perjeta and Herceptin, and in fact, in the UK, 90% of patients treated with Perjeta and Herceptin changed their treatment to Phesgo one year after Pesco was launched, so Perjeta and Herceptin in Korea also A significant number of patients receiving treatment are expected to switch to Pesco.

 

Meanwhile, Phesgo, a fixed-dose subcutaneous injection, confirmed non-inferior blood concentration and complete remission data compared to the intravenous Perjeta-Herceptin combination therapy in phase 3 clinical trial of FeDeriCa and confirmed a similar safety profile.

 

Also, according to the phase 2 clinical PHranceSCa study on patient preference, 85% of patients preferred subcutaneous treatment to intravenous administration because of a shorter stay in the hospital and more convenient treatment administration.

 

In addition, 87% of the patients who participated in the study responded that they would proceed with Pesco for the remaining breast cancer treatment.