On July 23, 2020, the first prescription of vilbutuximab was prescribed in China.
Trade name: Amway@
Indications: for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (salcl) and classical Hodgkin's lymphoma (CHL) with CD30 positive in adults.
The antibody coupled drug (ADC), brentuximab vedotin (adcetris), was jointly developed by Seattle genetics and Takeda tumor millennium. It was first marketed in the United States in 2011. The antibody in this drug is CD30 antibody brentuximab; the drug toxin is monomethyl auristatin e (MMAE), a synthetic derivative of rabbit toxin 10, which can effectively inhibit mitosis by inhibiting tubulin polymerization.
So far, adcetris has been approved by more than 70 countries around the world. So far, this product is the most successful ADC in the field of hematological oncology in the world. Its approved indications mainly focus on classical Hodgkin's lymphoma and anaplastic large cell lymphoma. In the United States, adcetris has six indications for the following adult patients:
(1) Untreated systemic anaplastic large cell lymphoma (salcl) or other peripheral T-cell lymphoma (PTCL) expressing CD30 were used in combination with chemotherapy CHP (cyclophosphamide, adriamycin and prednisone);
(2) Patients with untreated stage III or IV classical Hodgkin's lymphoma (CHL) were treated with chemotherapy;
(3) Patients with high risk of recurrence or progression after autologous hematopoietic stem cell transplantation (auto HSCT);
(4) Patients with CHL after failure of autologous hematopoietic stem cell transplantation (auto HSCT) or at least two previous chemotherapy regimens that are not suitable for non HSCT;
(5) Salcl after failure of at least one previous multi drug chemotherapy regimen;
(6) Primary cutaneous anaplastic large cell lymphoma (PCALCL) or mycosis fungoides (MF) expressing CD30 were previously treated systematically.
Sales performance
Adcetris had global sales of $523 million in 2016 and $640 million in 2017. Seattle genetics has left adcetris with commercial rights in the United States and Canada, while Takeda has commercial rights in other countries and regions. Seattle genetics and Takeda share the development cost of adcetris in a 50:50 ratio, with the exception of Japan, where Takeda is solely responsible for the development cost in Japan. Takeda was responsible for regional sales of $397 million in fiscal year 2018. In 2020, Seattle genetics predicts that the annual performance of the United States and Canada will reach up to US $700 million.
Previously, clarivate, a medical data service provider, predicted that the global market of the drug will reach 1.17 billion US dollars in 2020, and will exceed US $2 billion in 2024 as the indications continue to expand.
eference resources:
NMPA/CDE/FDA；
Drug melting circle data;
Public disclosure of related companies;
http://www.seattlegenetics.com/products/adcetris-us;
Performance in the first half of 2020: https://investor.seattlegenetics.com/events-and-presentations/event-details/2020/Second-Quarter-2020-Financial-Results/default.aspx ;
https://www.adcetris.com/;
https://www.adcetris.com/pi ;
https://www.businesswire.com/news/home/20200402005319/zh-CN ;
Takeda adcetris (brentuximab vedotin) combined with CHP (cyclophosphamide, doxorubicin and prednisone) was used in adult patients with previously untreated systemic anaplastic large cell lymphoma;
http://www.cde.org.cn/spxxgs.do?method=show&acceptidCode=a084a79ec25bd7ea26ca11cb8cccd3be ; and so on.
