Is Alpelisib-Piqray on the market?

Alpelisib (Alpelisib)-Piqray was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2019. It is the first approvedPI3K inhibitor for the treatment of It is used to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer in postmenopausal women and male patients. It can be used in combination with fulvestrant. Apelvis is sold under the brand name Piqray and is available as an oral tablet.

In order to initiate treatment with Apelvis, patients will need to have an FDA-approved diagnostic test confirm the presence of the PIK3CA mutation in tissue and/or liquid biopsy sample collection. Therefore, the FDA also approvedtherascreen PIK3CA RGQ PCR kit. Apellis was approved for medical use in the EU in July 2020. The benefits of Apelis outweigh its risks, and combined with fulvestrant it increases the time before disease progression in patients with advanced or spread HR-positive and HER2-negative breast cancer. In terms of side effects of the drug, the main concern is high blood sugar levels, which can lead to diabetes and intestinal problems, but steps are recommended to control this.

The original drug of Apellis is not marketed in the country and therefore cannot be included in medical insurance. There are European and Indian versions of the original Apelvis drug sold overseas. The ingredients are basically the same. The price of the European version of 150mg*56 tablets per box may be more than 4 RMB 40,000 ( (The price may fluctuate due to the exchange rate), The price of the Indian version150mg*28 tablets per box may be more than 5,000 yuan (the price may fluctuate due to the exchange rate). There are currently no generic versions of Apelvis produced and marketed.