The FDA has awarded AstraZeneta Imfinzi an orphan drug to treat small cell lung cancer

, the British pharmaceutical giant, recently announced that the U.S. Food and Drug Administration (FDA) has granted the PD-L1 oncology immunotherapy Imfinzi (durvalumab) to treat small cell lung cancer (SCLC) orphan drug qualification.
Orphan medicine refers to the medicine used to prevent, treat and diagnose rare diseases, which is the general term for a very low incidence of disease, also known as "orphan disease". In the U.S., rare diseases are disease types with fewer than 200,000 people, and incentives for the development of rare disease drugs include incentives for clinical development, such as tax credits related to clinical trial costs, FDA user fee deductions, FDA assistance in clinical trial design, and a seven-year market exclusive period after the drug is approved for market.
Lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is roughly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which SCLC accounts for about 15%. About two-thirds of SCLC patients are diagnosed with a widespread disease, in which cancer has spread widely throughout the lungs or to other parts of the body. SCLC is an invasive, fast-growing cancer that relapses and progresses rapidly, despite initially responding to platinum-containing chemotherapy. The prognostics were particularly poor, with only 6% of SCLC patients surviving five years after diagnosis.
In June of this year, the phase III clinical study CASPIAN of Imfinzi's first-line treatment of extensive stage small cell lung cancer (ES-SCLC) reached its primary endpoint, and the results showed that the total survival period (OS) of the Imfinzi-chemotherapy treatment group was statistically and clinically significant compared to that of the chemotherapy group. At present, AstraZeneta is also conducting another Phase III clinical study, ADRIATIC, which will be treated by Imfinzi after SCLC patients receive simultaneous chemotherapy (CCRT).
Imfinzi is a PD-L1 immunotherapy that targets the binding of cellular programmed death factor lilog 1 (PD-L1), blocks the interaction of PD-L1 with PD-1 and CD80, fights the immune evasion strategy of tumors, and releases the inhibition of the immune response.
currently, Imfinzi has been approved by many countries and regions (including Hong Kong and Macau, China) for the treatment of patients with advanced bladder cancer who have been treated in the past.In the area of lung cancer, Imfinzi has been approved by more than 45 countries worldwide (including the United States, the European Union, Japan) for the treatment of non-removable partial late stage (Stage III) NSCLC patients. This approval is based on data from the Phase III study PACIFIC study. In early June, three-year OS data released at the annual meeting of the American Society of Clinical Oncology (ASCO) showed that persistent and sustained OS benefits were observed in patients with non-excisive phase III NSCLC conditions that did not progress after simultaneous chemotherapy (CRT): three-year OS rates were 57% in the Imfinzi treatment group, the medium OS was not yet achieved, and the three-year OS rate in the placebo group was 43.5% and the medium OS was 29.1 months. Based on this result, Imfinzi became the first immunotherapy to be shown to have a three-year survival benefit in the non-excisive Phase III NSCLC population.
Currently, AstraZenecom is conducting a large-scale clinical project to evaluate Imfinzi as a monotherapy and a combination therapy for NSCLC, SCLC, bladder, head and neck cancer, liver cancer, cervical cancer, bile duct cancer and other solid tumors. (Bio Valley)