Darolutamide

THE PROSTATE CANCER FOUNDATION AND BAYER ANNOUNCE FIRST EVER BAYER-PCF DAROLUTAMIDE CHALLENGE AWARDS

Retrieved on: 
Wednesday, October 25, 2023

LOS ANGELES, Oct. 25, 2023 /PRNewswire/ -- The Prostate Cancer Foundation (PCF) and Bayer today announced two 2023 Bayer-PCF Darolutamide Challenge Awards totaling $2 million to support clinical investigations on darolutamide in prostate cancer.

Key Points: 
  • LOS ANGELES, Oct. 25, 2023 /PRNewswire/ -- The Prostate Cancer Foundation (PCF) and Bayer today announced two 2023 Bayer-PCF Darolutamide Challenge Awards totaling $2 million to support clinical investigations on darolutamide in prostate cancer.
  • In 2019, the U.S. Food and Drug Administration approved Bayer's Nubeqa® (darolutamide), an androgen receptor inhibitor (ARI), for the treatment of adults with non-metastatic, castration-resistant prostate cancer (nmCRPC).
  • In 2022, darolutamide was FDA-approved in combination with docetaxel chemotherapy for adults with metastatic hormone-sensitive prostate cancer (mHSPC), or metastatic prostate cancer patients receiving their first line of hormonal treatment.
  • The teams awarded 2023 Bayer-PCF Darolutamide Challenge Awards are:
    Co-Investigators: Heather Jacene, MD, Mary-Ellen Taplin, MD, Jacob Berchuck, MD, all of Dana-Farber Cancer Institute; Steve Balk, MD, Beth Israel Deaconess Medical Center

Celcuity Enters into a Clinical Trial Collaboration and Supply Agreement with Bayer to Provide Nubeqa® (darolutamide) for Planned Phase 1b/2 Clinical Trial

Retrieved on: 
Tuesday, August 22, 2023

As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.

Key Points: 
  • As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.
  • “We are excited that Bayer is providing darolutamide for this important Phase 1b/2 clinical trial,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity.
  • “Darolutamide is structurally unique to other ARI’s, with an excellent efficacy and differentiated tolerability profile coupled with minimal drug-drug interactions, making it an ideal combination partner for gedatolisib.
  • Our goal is to address the significant need for new therapeutic options for patients with metastatic castration resistant prostate cancer.”

Darolutamide approved for additional prostate cancer indication in China

Retrieved on: 
Monday, March 20, 2023

The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved in China for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Darolutamide receives EU approval for additional indication in prostate cancer

Retrieved on: 
Wednesday, March 1, 2023

The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved 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.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with an additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

Darolutamide receives approval for additional prostate cancer indication in Japan

Retrieved on: 
Monday, February 27, 2023

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Key Points: 
  • The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evauate its potential across prostate cancer patients from the early- to the late-stage of this disease.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer

Retrieved on: 
Friday, January 27, 2023

Darolutamide is already approved 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.

Key Points: 
  • Darolutamide is already approved 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.
  • The final decision from the European Commission on the marketing authorisation is expected in the coming months.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.
  • Bayer is responsible for global commercialisation, with co-promotion from Bayer and Orion in certain European markets, e.g.

U.S. FDA approves additional indication of darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC)

Retrieved on: 
Monday, August 8, 2022

Darolutamide in combination with docetaxel and ADT demonstrated a 32.5% reduction in the risk of death compared to docetaxel plus ADT.

Key Points: 
  • Darolutamide in combination with docetaxel and ADT demonstrated a 32.5% reduction in the risk of death compared to docetaxel plus ADT.
  • The compound is also being investigated in further studies across various stages of prostate cancer.
  • Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting.
  • Hahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic Castration-Sensitive Prostate Cancer: Optimizing Patient Selection and Treatment.

POINT Biopharma announces appointment of Chris Horvath as EVP, Commercial

Retrieved on: 
Tuesday, June 21, 2022

INDIANAPOLIS, June 21, 2022 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life changing radiopharmaceuticals, today announced the appointment of Chris Horvath, as Executive Vice President, Commercial. Mr. Horvath brings almost twenty years of experience in the pharmaceutical industry, having led or worked on the launch of a number of key oncology products, including Pluvicto (lutetium 177Lu vipivotide tetraxetan), Locametz (gallium 68Ga gozetotide), Nubeqa (darolutamide), and Zytiga (abiraterone acetate). In his new role at POINT, Mr. Horvath will lead the commercial strategy for POINT’s pipeline.

Key Points: 
  • In his new role at POINT, Mr. Horvath will lead the commercial strategy for POINTs pipeline.
  • Mr. Horvath began his career as a scientist, working at both DuPont and Novartis Institutes for BioMedical Research.
  • He then transitioned to commercial roles of increasing responsibility at Janssen, Dendreon, Merck, Bayer, and most recently Advanced Accelerator Applications (Novartis).
  • Im extremely pleased to join the POINT Biopharma team and be a part of their next phase of growth, said Mr. Horvath.

NeoTX Therapeutics promotes Marcel Rozencweig, M.D., to President and welcomes Scott Z. Fields, M.D., as new Chief Medical Officer

Retrieved on: 
Monday, January 31, 2022

REHOVOT, Israel, Jan. 31, 2022 /PRNewswire/ --NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, announced the promotion of current CMO, Marcel Rozencweig, M.D., to President and the appointment of Scott Z.

Key Points: 
  • REHOVOT, Israel, Jan. 31, 2022 /PRNewswire/ --NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, announced the promotion of current CMO, Marcel Rozencweig, M.D., to President and the appointment of Scott Z.
  • Fields, M.D., as the new chief medical officer, effective tomorrow, Feb. 1, 2022.Dr.
  • "Additionally, as a founding member of NeoTX, it gives me great pleasure to welcome Dr. Fields to our leadership team."
  • "I'm thrilled to join NeoTX at this time of important growth and evolution of the company," said Dr. Fields.

ARASENS trial with darolutamide in combination with docetaxel and androgen deprivation therapy meets primary endpoint of significantly increasing overall survival in patients with metastatic hormone-sensitive prostate cancer

Retrieved on: 
Friday, December 3, 2021

In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to placebo, docetaxel and ADT.

Key Points: 
  • In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to placebo, docetaxel and ADT.
  • The results show that darolutamide, a compound discovered by Orions scientists, in combination with docetaxel and androgen deprivation therapy improves overall survival for patients with metastatic hormone-sensitive prostate cancer.
  • Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT.
  • Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.