AstraZeneca plc (ADR) (NYSE:AZN) Secures Regulatory Approval For Imfinzi Label Expansion From The FDA


AstraZeneca plc (ADR) (NYSE:AZN) recently made it publicly known that it has been given the nod for the second indication of Imfinzi by the Food and Drug Administration (FDA).

The biopharma had filed for a label expansion of its PD-L1 inhibitor called Imfinzi so that it can be used as a treatment for patients with non-small cell lung cancer (NSCLC) which is in the third stage and cannot be removed surgically. The treatment will particularly be aimed at patients whose condition has not advanced as a result of radiation therapy and platinum-based chemotherapy. The approval of the drug by the FDA marks a major win for AstraZeneca because it will propel the company into a market worth billions especially through a drug that has previously been overtaken by rivals.

The approval of if the treatment is also a huge step forward for the biopharma because it happens to be the first treatment that has been approved for treating NSCLC. This gives the company a head start and an advantageous position over its competition. Imfinzi was first approved by the FDA in May last year for treating second line advanced bladder cancer and it managed to rake in $19 million in sales just that year. The second indication of the treatment by the FDA should thus guarantee more sales from the drug.

“The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy,” pointed out Dave Fredrickson, AstraZeneca’s Executive Vice President and who is also the head of the company’s oncology division.

The announcement about the recent approval of Imfinzi for treating NSCLC influenced an uptick in the company’s shares. AstraZeneca is also continuing the development of the drug as a combination therapy and also as a monotherapy for NSCLC and other types of cancer. Some of them include blood, hepatocellular, gastric and pancreatic cancer.

AstraZeneca stock closed Monday’s trading session at $33.93 after a slight decline of 0.26 percent compared to the value of the stock during the previous trading close.


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