AstraZeneca (AZN) Scores FDA Approval for Datroway, First TROP2 ADC for Lung Cancer

AstraZeneca PLC (NASDAQ:AZN) is one of the 12 stocks that will make you rich in 10 years. On June 23, the company announced that the FDA had granted accelerated approval to Datroway for the treatment of adult patients with non-small cell lung cancer (NSCLC).

A researcher in a lab coat working with a microscope, studying a biopharmaceutical drug.

Datroway is the first and only TROP2-directed antibody-drug conjugate (ADC) approved in the U.S. for lung cancer. The drug is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The companies signed a global collaboration agreement in July 2020, valued at up to $6 billion. As part of the agreement, Daiichi Sankyo maintains exclusive rights in Japan, while both companies share responsibilities elsewhere.

The approval followed a Priority Review and Breakthrough Therapy Designation by the FDA, reflecting the drug’s potential to address an unmet medical need. Continued approval may depend on verification of clinical benefit in a confirmatory trial, as is standard for accelerated approvals. Following the approval, AstraZeneca will pay Daiichi Sankyo a $45 million milestone payment for the NSCLC indication, as stipulated in their 2020 collaboration agreement.

AstraZeneca PLC (NASDAQ:AZN) is a global biopharmaceutical company. It discovers, develops, manufactures, and markets prescription medicines across disease areas like oncology, cardiovascular, renal and metabolism, respiratory, immunology, vaccines, and rare diseases. Its leading products include Tagrisso, Imfinzi, Farxiga, Brilinta, Symbicort, and Soliris.

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