On Thursday, AstraZeneca that the U.S. Food and Drug Administration (FDA) will give a priority review to its experimental breast cancer treatment called DS-8201. This could put AstraZeneca in stiff competition with its rival Roche.
The UK-based pharmaceutical company said, “The FDA accepted AstraZeneca’s application and granted the treatment, trastuzumab deruxtecan, a priority review for the treatment of HER2-positive metastatic breast cancer.”
In March, the pharma giant agreed to dole out nearly $7 billion to team up with Japan-based Daiichi Sankyo on the experimental breast cancer treatment, challenging directly to one of the world’s biggest cancer drug manufacturers, Roche.
DS-8201 belongs to the class of drugs called Antibody-Drug Conjugates (ADC), which has a direct action on the HER2 protein, a trigger factor of cancer or uncontrolled cell growth in more than 20 percent of breast cancer cases. The drug is similar to Roche’s best-seller breast cancer drug Herceptin, which also targets HER2 protein.
The drug showed promising results in a clinical trial in May.
The priority review is one of the parts of the FDA’s process to bring drugs, which are effective for serious or rare medical conditions, faster to the market. The review takes about six months for approval than standard 10 months.
It is expected that the decision of the FDA on trastuzumab deruxtecan will be made in the second quarter of 2020. AstraZeneca is expected to report third-quarter results of clinical trials by next week. The company has been venturing into cancer drug after its sales went down because of patent losses on its older medications.
