AstraZeneca (AZN) Gets EU Nod for Improved Imfinzi Dosing

Zacks Equity Research

AstraZeneca AZN announced that the European Commission and regulatory authority in U.K. granted marketing approval for a new four-week, fixed-dose regimen of its PD-L1 inhibitor, Imfinzi in the approved indication of unresectable non-small cell lung cancer (NSCLC) after platinum-based chemoradiation therapy. Imfinzi is presently administered as a weight-based dosing of 10mg/kg every two weeks. The 1500 mg dosing regimen is available to patients weighing more than 30 kgs.

The four-week, fixed-dose regimen (1500 mg) will reduce patients’ medical visits by half, thereby improving patent convenience. The less-frequent dosing regimen becomes particularly important amid this pandemic as it will help avoid unnecessary risk of exposure to infection for lung cancer patients who are more vulnerable to complications from COVID-19.

The EU approval was expected in December as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended marketing authorization for the fixed-dose regimen of Imfinzi.

The new dosing regimen of Imfinzi was approved in the United States in November for approved indications of stage III NSCLC after chemoradiation therapy and previously-treated advanced bladder cancer.

In the past six months, AstraZeneca’s shares have lost 12.5% against an increase of 3.7% for the industry.



Imfinzi recorded sales of $148 billion in the first nine months of 2020, mainly driven by strong demand in lung cancer patients. Imfinzi is also being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III trials in combination with tremelimumab in hepatocellular carcinoma (HCC, liver cancer), small cell lung cancer, metastatic urothelial cancer, head and neck squamous cell carcinoma (HNSCC) in earlier settings in NSCLC, among others

Other PD-L1 inhibitors on the market are Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio.

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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