AstraZeneca's Imfinzi (Durvalumab) Receives FDA Approval for New 1500mg Fixed-Dose Regimen Every Four Weeks

November 21, 2020 /Bio ValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the U.S. Food and Drug Administration (FDA) has approved a new dosing option for the anti-PD-L1 therapy Imfinzi (brand name: Imfinzi; generic name: durvalumab): a fixed dose of 1500 mg administered once every 4 weeks, for previously approved indications in non-small cell lung cancer (NSCLC) and prostate cancer. Currently, this dosing regimen is also under regulatory review in other countries and regions, including the European Union, where it has qualified for accelerated assessment.

Previously, the approved dosage of Imfinzi for non-small cell lung cancer (NSCLC) and bladder cancer indications was weight-based (10 mg/kg every 2 weeks). With this approval, Imfinzi offers a new dosing regimen (fixed dose of 1500 mg every 4 weeks) for patients with unresectable stage III NSCLC following chemoradiotherapy and for patients with previously treated advanced bladder cancer. This regimen is consistent with the approved dosage for extensive-stage small cell lung cancer (ES-SCLC) (fixed dose of 1500 mg) and will be available as an alternative to the weight-based 10 mg/kg every-2-weeks regimen for patients weighing >30 kg.

This new 4-week dosing regimen will enable physicians to halve the number of clinic visits and provide patients with a more convenient treatment option. This approval is based on multiple ImfinziClinical Trialdata, including the results of the Phase III CASPIAN trial in ES-SCLC, which employed a fixed-dose regimen of 1500 mg administered every 4 weeks during the maintenance phase.

City of Hope Cancer Center, Los Angeles, CaliforniaTumorVictoria M. Villaflor, MD, Clinical Professor in the Department of Therapeutics Research, stated: “This new 4-week dosing regimen allows physicians to halve the number of visits required for critical cancer treatment, offering patients a more convenient therapeutic option. Furthermore, it helps limit potential exposure to infection in healthcare settings for individuals who are particularly vulnerable to complications from COVID-19.”

AstraZenecaTumorDave Fredrickson, Executive Vice President of the Business Unit, stated: “The approval of this new dosing regimen across multiple indications reflects our ongoing commitment to improving patient experience and ensuring continuity of care—a priority at all times, particularly during the COVID-19 pandemic. Cancer does not wait, and our work is to provide patients with treatment options that acknowledge the challenges the COVID-19 pandemic has posed to cancer care, enabling them to see their doctors when truly needed while avoiding exposure to preventable healthcare-associated infections.”

Lung cancer is the leading cause of cancer-related deaths in both men and women, accounting for approximately one-fifth of all cancer deaths. Lung cancer is broadly classified into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with SCLC comprising approximately 15% of cases. Stage III (locally advanced) NSCLC is typically subdivided into stages IIIA, IIIB, and IIIC, based on the extent of local spread and resectability. Unlike stage IV lung cancer, which involves distant metastasis, stage III lung cancer has the potential for clinical cure.

Imfinzi (durvalumab) is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blockingTumorImmune evasion and release of suppressed immune responses.

To date, Imfinzi has been approved in multiple countries (including the United States, Japan, China, and the entire European Union) for the curative treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Furthermore, Imfinzi has also been approved in more than 10 countries, including the United States, for the treatment of patients with advanced bladder cancer who have previously received platinum-containing chemotherapy.

Based on data from the Phase III CASPIAN trial, Imfinzi in combination with standard-of-care (SoC) chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) has received approval in the United States, the European Union, Japan, and several other countries.

Currently, AstraZeneca is conducting a large-scale clinical program to evaluate Imfinzi as monotherapy and in combination with tremelimumab and other agents for the treatment of NSCLC, SCLC, bladder cancer, head and neck cancer,Liver Cancer, cervical cancer, biliary tract cancer, and other solid tumors.

Tremelimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocks CTLA-4 activity, promotes T-cell activation, and initiatesTumorimmune response, promoting cancer cell death. Tremelimumab and Bristol-Myers Squibb's marketed antibody drug Yervoy (ipilimumab) target the same checkpoint, CTLA-4. (Bioon.com)

Original Source: Imfinziapproved in the US for less-frequent, fixed-dose use