Tumor immunotherapy upgrade! AstraZeneta's New 4-Week Fixed Dose Program is under FDA priority review!

Aug 18, 2020 // -- AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental biologics license application (sBLA) for the anti-PD-L1 therapy Imfinzi (Infinfan, generic name: durvalumab, duvalyu monoanti).
the sBLA involves a new 4-week, fixed-dose treatment for approved non-small cell lung cancer (NSCLC) and prostate cancer.
the FDA has designated a target date for the Prescription Drug User Charge Act (PDUFA) as the fourth quarter of 2020.
currently, Imfinzi's approved doses in NSCLC and bladder cancer adaptation are based on weight (10 mg/kg, once every 2 weeks).
If sBLA is approved, Imfinzi may offer a new administration option (fixed dose 1500 mg, once 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, consistent with the approved dose of broad-stage small cell lung cancer (ES-SCLC) (fixed dose 1500 mg).
the sBLA 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.
Dave Fredrickson, executive vice president of AstraZeneta's Oncology business unit, said: "This new, less frequent approach to non-small cell lung and bladder cancer will simplify and improve treatment, achieve continuity of care, and minimize the risk of infection exposure to a medical environment.
particularly urgent during the current COVID-19 pandemic, as doctors care for patients with high-risk COVID-19 complications.
we are working with regulators in the United States and other countries to provide a four-week, fixed-dose Imfinzi treatment to patients around the world as soon as possible.
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 extent of local metastasis of cancer cells and the ability to perform surgery, is usually divided into three types: IIIA, IIIB, and IIIC.
stage III lung cancer is likely to be clinically cured, 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, imfinzi Joint Standard Care (SoC) chemotherapy first-line treatment for broad-stage non-small cell lung cancer (ES-SCLC) was approved in the United States.
application is also currently under review by EU and Japanese regulators.
Currently, AstraZenecom is conducting a large-scale 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: Imfinzi granted FDA Priority Review for less-frequent, fixed-dose use.