Bicalutamide

Bayer and Orion Expand Development Program for NUBEQA® (darolutamide) in Prostate Cancer

Retrieved on: 
Monday, February 8, 2021

Bayer and Orion Corporation are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in prostate cancer.

Key Points: 
  • Bayer and Orion Corporation are expanding the global clinical development program for the oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) in prostate cancer.
  • NUBEQA has already shown in men with non-metastatic castration-resistant prostate cancer (nmCRPC) that it extends metastasis-free and overall survival, said Scott Z.
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Effect of Other Drugs on NUBEQA Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity.

Worldwide Prostate Cancer Industry to 2024 - Rising Public Awareness towards Prostate Cancer Treatment is Driving Growth

Retrieved on: 
Monday, December 7, 2020

3.1 Global Prostate Cancer Market: An Analysis

Key Points: 
  • 3.1 Global Prostate Cancer Market: An Analysis
    3.1.2 Global Prostate Cancer Drug Market by Country (US, China, ROW)
    3.1.3 Global Prostate Cancer Market by Drugs (Enzalutamide, Abiraterone acetate, Leuprorelin, Goserelin, Cabazitaxel, Bicalutamide, Radium 223 dichloride, others)
    3.2 Global Prostate Cancer Market: Drug Analysis
    4.1 The US Prostate Cancer Market: An Analysis
    4.1.2 The US Prostate Cancer Market by Drug (Enzalutamide, Abiraterone acetate, Leuprorelin, Radium 223 dichloride, others)
    4.2 The US Prostate Cancer Market: Drug Analysis
    4.3 China Prostate Cancer Market: An Analysis
    4.3.2 China Prostate Cancer Market by Drug (Abiraterone acetate, Bicalutamide, Docetaxel, Leuprorelin, Goserelin, Triptorelin, Others)
    4.4 China Prostate Cancer Market: Drug Analysis

Global Prostate Cancer Market (2020 to 2024) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Monday, November 30, 2020

3.1 Global Prostate Cancer Market: An Analysis

Key Points: 
  • 3.1 Global Prostate Cancer Market: An Analysis
    3.1.2 Global Prostate Cancer Drug Market by Country (US, China, ROW)
    3.1.3 Global Prostate Cancer Market by Drugs (Enzalutamide, Abiraterone acetate, Leuprorelin, Goserelin, Cabazitaxel, Bicalutamide, Radium 223 dichloride, others)
    3.2 Global Prostate Cancer Market: Drug Analysis
    4.1 The US Prostate Cancer Market: An Analysis
    4.2 The US Prostate Cancer Market: Drug Analysis
    4.3 China Prostate Cancer Market: An Analysis
    4.4 China Prostate Cancer Market: Drug Analysis
    View source version on businesswire.com: https://www.businesswire.com/news/home/20201130005511/en/

Xencor Presents Updated Data From the DUET-2 Phase 1 Study of XmAb20717, PD-1 x CTLA-4 Bispecific Antibody, at the SITC Annual Meeting

Retrieved on: 
Monday, November 9, 2020

Though data are early, we are especially encouraged by initial activity in patients with metastatic castration-resistant prostate cancer.

Key Points: 
  • Though data are early, we are especially encouraged by initial activity in patients with metastatic castration-resistant prostate cancer.
  • We are also planning additional cohorts in selected populations within DUET-2, based on clinical activity and unmet medical need.
  • Data are also still maturing in cohorts of patients with renal cell carcinoma, and those with cancers without approved checkpoint therapies, including prostate cancer.
  • In the studys escalation phase, 34 patients have been treated with doses escalating from 0.15 to 10 mg/kg.

Leronlimab Shows Early, but Promising Clinical Responses in First Two Patients Recovering from Stroke

Retrieved on: 
Monday, October 26, 2020

A second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer.

Key Points: 
  • A second stroke patient was receiving treatment with leronlimab as part of her therapy for breast cancer.
  • Therefore, we are accelerating the filing of a Phase 2 protocol to evaluate leronlimabs potential as a therapeutic for stroke recovery.
  • No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab.
  • Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy Showed a Statistically Significant Improvement in Overall Survival with Proven Efficacy and Tolerability in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, May 13, 2020

These data add to the growing evidence for darolutamide as an effective treatment option with proven tolerability that extends patients lives and delays cancer symptoms.

Key Points: 
  • These data add to the growing evidence for darolutamide as an effective treatment option with proven tolerability that extends patients lives and delays cancer symptoms.
  • Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo.
  • Effects of NUBEQA on Other Drugs NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter.
  • Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for nonmetastatic castration-resistant prostate cancer (nmCRPC).

Veru Reports Positive Clinical Results from VERU-111 Phase 1b/2 Trial in Men with Metastatic Castration-Resistant Prostate Cancer, Advancing to Pivotal Phase 3 Clinical Program

Retrieved on: 
Tuesday, May 5, 2020

A drug with a different mechanism of action, like VERU-111, is greatly needed for men who have metastatic castration and androgen blocking agent resistant prostate cancer.

Key Points: 
  • A drug with a different mechanism of action, like VERU-111, is greatly needed for men who have metastatic castration and androgen blocking agent resistant prostate cancer.
  • The Phase 1b portion of the Phase 1b/2 clinical study enrolled 39 subjects from 7 clinical sites in the United States.
  • Blood levels of VERU-111 were measurable at doses as low as 9 mg per day and VERU-111 drug levels increased with higher doses.
  • As for safety, the MTD of VERU-111 was determined to be 72mg (3 of 11 men had reversible Grade 3 diarrhea).

Myovant Sciences Submits New Drug Application (NDA) to the FDA for Once-Daily, Oral Relugolix for the Treatment of Men with Advanced Prostate Cancer

Retrieved on: 
Tuesday, April 21, 2020

Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group.

Key Points: 
  • Major adverse cardiovascular events were reported in 2.9% of men in the relugolix group versus 6.2% of men in the leuprolide acetate group.
  • Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men intheU.S.
  • Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S.
  • Myovant is developing relugolix as a monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.

Veru Initiates Phase 2 Clinical Trial of VERU-111, First-in-Class, Oral, Advanced Prostate Cancer Drug

Retrieved on: 
Wednesday, February 26, 2020

This prechemotherapy stage in men is currently one of the fastest growing unmet medical needs in advanced prostate cancer.

Key Points: 
  • This prechemotherapy stage in men is currently one of the fastest growing unmet medical needs in advanced prostate cancer.
  • We are developing VERU-111 to be the next go to therapy in men with advanced prostate cancer who fail a novel androgen blocking agent.
  • Earlier this month in commenting on preliminary results from the Phase 1b portion of the VERU-111 clinical study, the Company noted evidence of prostate cancer antitumor activity.
  • VERU-111 is being evaluated in men with metastatic castration and androgen-blocking agent resistant prostate cancer in an open label Phase 1b/2 clinical trial.

Veru Announces Positive Top-Line Interim Data from Phase 2 Clinical Trial of Zuclomiphene to Treat Hot Flashes in Men with Prostate Cancer on Androgen Deprivation Therapy

Retrieved on: 
Monday, January 13, 2020

A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled.

Key Points: 
  • A topline interim analysis was performed in which 93 men with ADT-induced hot flashes were enrolled.
  • Adverse events of special interest are side effects commonly seen with off label use of steroidal estrogens and progestins for hot flashes.
  • VERU-111 is being evaluated in men with metastatic castration and androgen-blocking agent resistant prostate cancer in an open label Phase 1b/2 clinical trial.
  • Veru plans to initiate a Phase 3 clinical trial for Zuclomiphene in the first half of 2020.