AstraZeneca PLC (AZN) Secures US Priority Review For Candidate Breast Cancer Treatment

AstraZeneca PLC (NYSE:AZN) is one of Goldman Sachs top healthcare stocks. On March 9, AstraZeneca PLC (NYSE:AZN) and Daiichi Sankyo secured Priority Review in the US for Enhertu, their candidate drug for patients with HER2-positive breast cancer.

AstraZeneca PLC (AZN) Secures US Priority Review For Candidate Breast Cancer Treatment

The priority review comes on the heels of the Food and Drug Administration granting Enhertu Breakthrough Therapy Designation, given its potential to offer significant improvements over available treatment options. The designation is poised to accelerate the development and regulatory review of the candidate drug, given its potential to treat a serious condition.

The FDA priority review asserts the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the DESTINY-Breast05 Phase III trial. Trial results underscored the candidate’s drug potential to reduce the risk of invasive disease recurrence or death by 53%. The safety profile was consistent and did not trigger any new safety concerns.

Enhertu is currently approved in more than 90 countries as a treatment option for HER2-positive metastatic breast cancer.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”

AstraZeneca PLC (NYSE:AZN) is a global, science-led biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. It specializes in treating major diseases across oncology, cardiovascular, renal, metabolism, respiratory, and immunology areas, generating billions in revenue from these therapeutic, life-changing medicines.

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