A New Launched Prostate Cancer Drug By Orion Pharma and Bayer Got Approval From The USFDA
A new launched prostate cancer drug by Orion pharma and Bayer got approval from USFDA. Approval of androgen receptor inhibitor i.e. darolutamide used in treatment of prostate cancer. This sanction by FDA is based on Phase III ARAMIS trial. Darolutamide trade name is Nubeqa and which is approved under Priority Review designation of FDA. This designation is reserved for those drugs which are provide important progress in the safety or effectiveness in the treatment of serious conditions. The non-metastatic castration-resistant prostate cancer (nmCRPC) has an increasing level of prostate-specific antigen in the blood. Prostate cancer is mostly diagnosed in men.
Treatment of this cancer after the diagnosis by hormone-receptor antagonists. These includes radiation treatment, surgery, and chemotherapy. Nubeqa product is manufacture and developed by both Orion and Bayer pharma corporation. Nubeqa (darolutamide) blocks the non-steroidal androgen receptor function. They also inhibit the growth of prostate cancer cell. Almost 73,000 men are diagnosed in the US with prostate cancer in 2019. Approximately 40% of these patients are suffering from prostate cancer. In this patient cancer is not spread in other body parts. Bayer company apply for approval of Nubeqa in the Japan, European Union (EU). Company also apply with other health authorities. Bayer pharma already launched Xofigo brand. This brand is used for metastatic prostate cancer.
Now company got approval for Nubeqa to sale in market with existing competitors. Patients having non-metastatic castration-resistant prostate cancer don’t show any symptoms they are usually asymptomatic. To diagnose the cancer in patient prostate-specific antigen(PSA) test is carried out. This is important to prevent further problems related cancer. A key person from Bayer pharma said that this is our victory. Bayer’s commitment to patients regarding the launching new cancer drug is completed. This drug is specially to treat prostate cancer in men at different stages. Nubeqa is new addition to our prostate cancer portfolio. Trial of evaluating darolutamide drug with metastatic hormone-sensitive prostate cancer patients is ongoing. This is expected to be completed in 2021 to 2022.