Bayer gets USFDA priority review for darolutamide plus docetaxel to treat metastatic hormone-sensitive prostate cancer

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Published On 2022-05-04 06:30 GMT | Update On 2022-05-04 14:26 GMT

Berlin: Bayer has announced that the U.S. Food and Drug Administration (USFDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).The application is being conducted under the FDA Oncology Center...

Berlin: Bayer has announced that the U.S. Food and Drug Administration (USFDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

The application is being conducted under the FDA Oncology Center of Excellence's (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.

"Bayer remains dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease," said Christine Roth, Member of the Executive Committee of Bayer's Pharmaceutical Division and Head of the Oncology SBU at Bayer. "The sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for darolutamide in combination with docetaxel to benefit men with mHSPC."

The sNDA is based on positive results from the pivotal Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival (OS) for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in men with mHSPC compared to ADT plus docetaxel, which were published in The New England Journal of Medicine.

Darolutamide is already approved in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Bayer recently submitted applications to the European Medicine Agency (EMA), the Ministry of Health, Labor and Welfare (MHLW) in Japan, and China's Center of Drug Evaluation (CDE). Additional submissions in mHSPC are planned globally.

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Bayer gets USFDA priority review for darolutamide plus docetaxel to treat metastatic hormone-sensitive prostate cancer

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

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