Is tremelimumab an orphan drug?

Tremelimumab/tremelimumab is an antiCTLA4 antibody and potential new drug. has received orphan drug designation (ODD) in the United States for the treatment of hepatocellular carcinoma (HCC), the most common type of liver cancer and non-small cell lung cancer. Tremelimumab is typically used with durvalumab, a PD-L1 inhibitor that also received orphan drug designation. But orphan designation does not mean the drug is safe or effective, nor does it guarantee approval by the U.S. Food and Drug Administration (FDA).

Tremelimumab was evaluated in combination withdurvalumab in multiple settings, including first-line metastatic non-small cell lung cancer. Preclinical/Clinical data suggest that both hypofractionated radiotherapy and low-dose radiotherapy have potentially beneficial immune effects; however, these radiotherapy regimens have not been prospectively tested in human patients with combined PD-L1/CTLA-4 dual blockade. PD-L1/CTLA-4 inhibition alone or in combination with radiotherapy resulted in durable responses in approximately 10% of patients and disease control in 30% of patients, making it a potential treatment option for the PD(L)-1 inhibitor-resistant patient population.

Tremelimumab/Tremelimumab is a new type of cancer immunotherapy drug. It has not yet been launched in China, so it cannot be included in the medical insurance. Domestic patients cannot yet purchase this drug. It is understood that the US version of temsitumumab original drug sold overseas may cost more than more than 3,000 US dollars per box, and the specification is 300mg/50mL (20mg/mL). The price is still relatively expensive. At present, we are not aware of the production and release of generic drugs of temsitumumab. For specific overseas prices and drug details, please consult Yaode Medical Consultants.