Tumor immunotherapy upgrade! AstraZenecom's New Dosing Scheme (1500mg once every 4 weeks) has been approved in the EU!

January 15, 2021 // -- AstraZeneca recently announced that the European Commission (EC) has approved a new dose option for anti-PD-L1 therapy Imfinzi (Infinfan, generic name: durvalumab, dovalyu monoanti) every 4 Mondays A secondary fixed dose of 1500 mg for approved non-small cell lung cancer (NSCLC) adaptation, specifically for 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 option (fixed dose of 1500 mg, once every 4 weeks) is consistent with the approved dose (fixed dose of 1500 mg) for broad-stage small cell lung cancer (ES-SCLC) and can be used in patients with local late-stage, non-removable NSCLC at a weight of >30 kg as an alternative to the weight-based 10 mg/kg administration option every 2 weeks.
U.S. regulatory, in November 2020, Imfinzi's dosage program (1500 mg at a four-week fixed dose) was approved by the FDA 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 EU EC 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. Dave Fredrickson, executive vice president of AstraZeneta's oncology business unit at
, said: "We are pleased to offer a four-week regimen to lung cancer patients in Europe to meet their immediate needs and help them maintain continuity of care during the COVID-19 pandemic.
we are committed to providing patients with treatment options to meet the challenges of the COVID-19 pandemic to their care.
lung cancer is the leading cause of cancer death in both men and women, accounting for about one-fifth of all cancer deaths.
are divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which NSCLC accounts for about 80-85%.
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 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.
origin of the original text: Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell cell lung