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Details:
Erleada® (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Lead Product(s): Apalutamide
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2023
Details:
APATIDE (generic version of Apalutamide) is a potent androgen receptor (AR) antagonist that selectively binds to the ligand-binding domain and blocks AR nuclear translocation or binding to androgen response elements. Product has been launched in India to treat prostate cancer.
Lead Product(s): Apalutamide
Therapeutic Area: Oncology Product Name: Apatide
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
ENV105 has been demonstrated to complement standard of care androgen targeted therapy with non-steroidal anti-androgens such as XTANDI® (enzalutamide) and Zytiga® (abiraterone acetate) in limiting therapeutic resistance to these drugs in a previous Phase II trial.
Lead Product(s): ENV-105,Apalutamide
Therapeutic Area: Oncology Product Name: ENV-105
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2022
Details:
ERLEADA® has shown a statistically significant improvement in overall survival with a consistent safety profile, while maintaining patients’ health-related quality of life in both approved indications of mCSPC and non-metastatic castration resistant prostate cancer (nmCRPC).
Lead Product(s): Apalutamide,Androgen deprivation therapy
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2022
Details:
Notably, the addition of apalutamide to ADT improved the MFS percentage among the Decipher high-risk patients to a level similar to the percentage among patients classified as Decipher low-to-average-risk.
Lead Product(s): Apalutamide
Therapeutic Area: Oncology Product Name: ARN-509
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2021
Details:
RYBREVANT is being studied in a comprehensive clinical development program for people with untreated advanced EGFR-mutated NSCLC, including the Phase 3 MARIPOSA trial studying RYBREVANT in combination with lazertinib.
Lead Product(s): Apalutamide,Androgen deprivation therapy
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
ERLEADA® is an androgen receptor inhibitor indicated for treatment of patients with non-metastatic castration-resistant prostate cancer. The TITAN study previously demonstrated statistically significant improvement in overall survival in patients receiving ERLEADA® plus ADT.
Lead Product(s): Apalutamide,Androgen deprivation therapy
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aragon Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2021
Details:
The ACIS study met its primary endpoint of radiographic progression-free survival (rPFS); however, combination treatment did not show significant benefit over the active control ZYTIGA® plus prednisone in key secondary endpoints, including overall survival (OS).
Lead Product(s): Apalutamide,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
ACIS was a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA and ZYTIGA plus prednisone compared to placebo and ZYTIGA plus prednisone in 982 patients with chemotherapy-naïve mCRPC who received ADT.
Lead Product(s): Apalutamide,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2021
Details:
Data from the ACIS study showed a meaningful increase in rPFS in evaluating the combination of apalutamide and abiraterone acetate plus prednisone in the treatment of metastatic castration-resistant prostate cancer.
Lead Product(s): Apalutamide,Abiraterone Acetate
Therapeutic Area: Oncology Product Name: JNJ-56021927
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2021
Details:
Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed second-generation antiandrogen therapy.
Lead Product(s): Masofaniten,Apalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 13, 2021
Details:
Erleada (apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Lead Product(s): Apalutamide
Therapeutic Area: Oncology Product Name: Erleada
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2020
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