US FDA accepts AstraZeneca and Mercks sNDA for Lynparza in combo with abiraterone and prednisone or prednisolone to treat patients with mCRPC
AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that a supplemental New Drug Application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone has been accepted and granted priority review by the US Food and Drug Administration (FDA) for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date in the fourth quarter of 2022.
In the US, prostate cancer is the second most common cancer in male patients. Approximately 10-20% of male patients with advanced prostate cancer are estimated to develop castration resistant prostate cancer (CRPC) within five years, and at least 84% of these men may develop metastases at the time of CRPC diagnosis. Patients with advanced prostate cancer have a particularly poor prognosis, and the five-year survival rate remains low.
Susan Galbraith, executive vice president, oncology R&D, AstraZeneca, said,
Let’s apply Data-Driven Pricing to Your APIs
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions!
Learn More!