Has Inavolisib been approved in the country?

Inavolisib (Inavolisib), as a PI3Kα inhibitor that has attracted much attention in recent years, has been officially approved in China and has been put on the market. However, due to its short time on the market, the price system is still in the stage of continuous improvement, so stable pricing information has not yet been available through public channels. The more common specifications on the market include 3mg7 tablets 4 plates and 9mg7 tablets 4 plates. They are new drug specification designs that are being promoted globally and are currently the packaging method commonly used by regulatory agencies in various countries.

However, although the drug has been launched in China, it has not yet been included in the national medical insurance catalog, which means that the actual purchase of the drug still has to be paid out of pocket, which is a large financial burden for some long-term treatment patients. As price negotiations or subsequent medical insurance evaluations proceed, changes may occur in the future, which is a trend that domestic patients are more concerned about.

In terms of indications, the core positioning of inaliset is very clear, and it is mainly used to treat patients with locally advanced or metastatic breast cancer who have been confirmed to have PIK3CA gene mutations, hormone receptor positive (HR+), and HER2 negative. Such patients often undergo adjuvant endocrine therapy and subsequently relapse or become resistant to endocrine therapy, requiring targeted therapeutic intervention. The approval of inaliset was based on the detection method of the FDA registration trial, which emphasized the combined use with palbociclib (Palbociclib) and fulvestrant (Fulvestrant). This is a standard regimen widely used in international guidelines. It aims to inhibit the CDK4/6 pathway and PI3Kα The dual role of signaling pathways enables more stable and targeted disease control. Overseas discussions on this combination focus mostly on the delay of long-term disease course and its potential advantages in the environment of endocrine resistance.

As domestic breast cancer treatment continues to improve, future screening of PIK3CA mutation populations, automated detection technology, medical insurance policy adjustments, and real-world data accumulation are likely to further promote the coverage of inaliside in the country.

Reference materials: https://www.itovebi-hcp.com/