Tumor immunotherapy upgrade! AstraZenecom's Imfinzi new dosing program (1500mg once every 4 weeks) is approved by the FDA!

Nov 21, 2020 // -- AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has approved a new dosage option for anti-PD-L1 therapy Imfinzi (Infinfan, generic name: durvalumab, dovalyu monoantigen): a fixed dose of 1500 mg every 4 weeks for previously approved non-small cell lung cancer (NCLC) and prostate cancer.
, the dosage programme is currently under regulatory review in other countries and regions, including the European Union, which has been eligible for accelerated assessment in the region.
, Imfinzi's approved doses in NSCLC and bladder cancer adaptation were based on weight (10 mg/kg, once every 2 weeks).
With this approval, Imfinzi offers a new administration option (a fixed dose of 1500 mg, every 4 weeks) in patients with non-removable stage III NSCLC after chemotherapy and in patients with advanced bladder cancer who have previously been treated. The approved dose (fixed dose of 1500 mg) for broad-stage small cell lung cancer (ES-SCLC) is consistent, and the program will be available to patients weighing >30 kg as an alternative to the weight-based 10 mg/kg administration option every 2 weeks.
the new four-week dosing program will give doctors the option to halve the number of visits and provide patients with a more convenient treatment option.
approval is based on data from several Imfinzi clinical trials, including the results of the ES-SCLC III CASPIAN trial, which used a fixed dose of 1500 mg once every 4 weeks during maintenance.
"This new four-week drug treatment gives doctors the option to halve the number of visits to critical cancer treatments and provides patients with a more convenient treatment option," said Dr. Victoria M. Villaflor, M.D., clinical professor in the Department of Oncology and Therapeutics at Hope Cancer Center in Los Angeles, California.
addition, it limits potential infections in the medical environment for those who are particularly vulnerable to COVID-19 complications.
Dave Fredrickson, executive vice president of AstraZeneta's Oncology business unit, said: "The approval of this new drug regimen covering all adaptations reflects our ongoing commitment to improving the patient experience and ensuring continuity of care, which is a priority at all times, especially during the COVID-19 pandemic.
The cancer doesn't wait, and our job is to provide patients with treatment options that recognize the challenges of the COVID-19 pandemic for cancer care, enabling them to see a doctor when they really need it and avoid exposure to preventable medically related infections."
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%.
Phase III (Local Progress) NSCLC, depending on the local transfer range of cancer cells and whether surgery can be performed, is usually divided into three types: IIIA, IIIB, and IIIC.
stage III lung cancer has the potential for clinical cure, unlike in patients with stage IV lung cancer.
Imfinzi (Infinfan, Dvaliyu monoanti) is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blocking tumor immune escape and releasing suppressed immune responses.
To date, Imfinzi has been approved in several countries (including the United States, Japan, China, and the European Union as a whole) for non-excisive, phase III non-small cell lung cancer (NSCLC) patients who have not progressed after receiving platinum-based chemotherapy-based simultaneous radiotherapy.
addition, Imfinzi has been approved in more than 10 countries, including the United States, for patients with advanced bladder cancer who have previously received platinum-containing chemotherapy.
based on data from the Phase III CASPIAN trial, the Imfinzi Joint Standard Care (SoC) chemotherapy first-line treatment of broad-stage non-small cell lung cancer (ES-SCLC) was approved by the United States, the European Union, Japan and a number of other countries.
Currently, AstraZenecom is conducting a major clinical project to evaluate Imfinzi as a monotherapy and a combination therapy for NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, cervical cancer, bile duct cancer and other solid tumors.
tremelimumab is a human monoclonal antibody that targets cytotoxic T lymphocyte antigen 4 (CTLA-4), blocks CTLA-4 activity, promotes T-cell activation, initiates tumor immune response, and promotes cancer cell death.
tremelimumab and Shishi Shiguibo have listed antibody drug Yeervoy (Ipimu monoanti) targeting the same target CTLA-4.
() original origin: Imfinzi approved in the US for less-frequent, fixed-dose use