Tumor immunotherapy upgrade! AstraZeneia Imfinzi's new dosing scheme (1500mg once every 4 weeks) is approved in the EU!

December 16, 2020 // -- AstraZeneca recently announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending approval of anti-PD-L1 therapy Imfinzi (Infinfan, generic name: durvalumab, dovalyu single resistance) A new dose option, a fixed dose of 1500 mg every 4 weeks, for approved non-small cell lung cancer (NSCLC) adaptation, specifically in adult patients with local late stage or non-removable NSCNC after receiving platinum-containing chemotherapy (CRT), tumor expression PD-L1 (≥1% tumor cells).
this new administration programme (fixed dose 1500 mg, once every 4 weeks) is consistent with the approved dose (fixed dose of 1500 mg) for extensive stage small cell lung cancer (ES-SCLC).
once approved, this new administration option will be available to patients with local late-stage, non-excisible NSCLC weighing >30 kg as an alternative to the weight-based 10 mg/kg administration option every 2 weeks.
U.S. regulatory aspect, imfinzi's dosage program (a four-week fixed dose of 1500 mg) was approved by the FDA in November for previously approved NSCLC and prostate cancer adaptations.
, 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 (fixed dose 1500 mg, every 4 weeks) in patients with non-excisive phase III NSCLC after chemotherapy and in patients with advanced bladder cancer who have previously been treated ), this is consistent with the approved dose of ES-SCLC (fixed dose 1500 mg), which will be available to patients weighing >30 kg as an alternative to the weight-based 10 mg/kg administration option every 2 weeks.
currently under regulatory review in other countries and regions.
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.
FDA approval and CHMP's recommended approval are based on data from several Imfinzi clinical trials, including the results of the NSCLC Phase III PACIFIC trial and the ES-SCLC III PHASE CASPIAN trial, the latest of which uses a fixed dose of 1500 mg every 4 weeks during maintenance.
"The four-week one-week dosing program will reduce the risk of exposure to infection in a medical setting and further strengthen our efforts to ensure that cancer patients with a high risk of complications during the pandemic receive ongoing care," said Jose Baselga, executive vice president of research and development at AstraZenetas.
we look forward to providing nSCLC patients in Europe with a new dosing option that reduces the number of visits by extending the dosing time from 2 weeks to 4 weeks.
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, Dovaliyu monoanti) is an 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 the healing treatment of non-extinable, stage III non-small cell lung cancer (NSCLC) patients who have not developed the disease after receiving platinum-based chemotherapy synchronous 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 recommended for approval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer