apalutamide / Generic mfg. - LARVOL DELTA

Apalutamide-associated rash combined with severe neutropenia and eosinophilia: a case report. (PubMed, AME Case Rep) - "The patient is currently receiving intramuscular injections of triptorelin pamoate (15 mg every 3 months), with prostate-specific antigen (PSA) under effective control. During apalutamide treatment, clinical follow-up and management should be intensified. After the occurrence of adverse events, relevant examinations should be performed promptly and early intervention should be implemented."

Journal • Castration-Resistant Prostate Cancer • Dermatology • Eosinophilia • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Infectious Disease • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Quantification of Belzutifan in Biological Samples: LC-MS/MS Method Validation and Pharmacokinetic Study in Rats. (PubMed, Biomed Chromatogr) - "Belzutifan and apalutamide (IS) were quantified on a symmetry shield (150 × 4.6 mm, 3.5 μm) column using acetonitrile and buffer (30:70% v/v) as the mobile phase, with a run time of 7 min. The results indicate linearity between 5 and 100 ng/mL concentration with r2 = 0.9997, which proved to be accurate with % recovery between 95.0% and 97.98%, along with other essential metrics within the accepted limits. The pharmacokinetic study demonstrates that the established LC-MS/MS method accurately quantifies the drugs in rat plasma and might be useful for routine quantification of belzutifan in biological matrices."

Journal • PK/PD data • Preclinical • Oncology • Von Hippel-Lindau Syndrome

Association of Race and Survival in Apalutamide Treated Patients from the TITAN and SPARTAN Phase 3 Trials (ESMO 2025) - No abstract available

Clinical • P3 data • Oncology

CHAMPION study (NCT05717582) : a prospective study of maximal-cytoreductive therapies for patients with de novo metastatic hormone-sensitive prostate cancer who achieve oligopersistent metastases during systemic treatment with apalutamide plus androgen deprivation therapy (ESMO 2025) - P2 | No abstract available

Clinical • Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Preliminary safety and clinical activity from a phase II study of apalutamide + carotuximab in advanced, castration-resistant prostate cancer (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Apalutamide for high-risk localized prostate cancer following radical prostatectomy- A new Horizon. (PubMed, Indian J Urol) - No abstract available

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Apalutamide - Induced Acquired Ichthyosis in an elderly patient: A case report (EADV 2025) - No abstract available

Case report • Clinical • Atopic Dermatitis • Dermatology • Immunology • Vitiligo

Treating apalutamide-induced toxic epidermal necrolysis with adalimumab and baricitinib in a patient with prostate cancer (EADV 2025) - No abstract available

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Steven-Johnson Syndrome

Outcomes for [177Lu]Lu-PSMA-617 with and Without Concurrent Use of Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration-resistant Prostate Cancer. (PubMed, Eur Urol Oncol) - "Among men with mCRPC previously exposed to an ARPI, continuation of the ARPI with [177Lu]Lu-PSMA-617 did not improve PSA50 response rates or OS after adjusting for cohort imbalances in known prognostic factors. Further post hoc analyses using large clinical trial data are needed."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prostate-Specific Antigen Reduction After Androgen Receptor Pathway Inhibitor Initiation: Real-World Comparison of Disease Progression Among Patients With Metastatic Castration-Sensitive Prostate Cancer. (PubMed, J Health Econ Outcomes Res) - " Patients with mCSPC initiating a first ARPI (ie, apalutamide, enzalutamide, abiraterone acetate, darolutamide) were identified using electronic medical record data linked to insurance claims in the United States (1/1/2016-9/30/2022). Early reduction of PSA levels by ≥90% within 6 months of ARPI initiation among patients with mCSPC in the real world is a robust indicator of treatment success, with improved long-term clinical outcomes, including survival and reduction in disease progression. These findings corroborate those of clinical trials and highlight the long-term benefits of an early and deep PSA response to ARPIs among real-world patients with mCSPC in the United States."

Journal • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

CARLHA-2: Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy (clinicaltrials.gov) - P3 | N=490 | Active, not recruiting | Sponsor: UNICANCER | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

VA STARPORT: Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (clinicaltrials.gov) - P2/3 | N=464 | Recruiting | Sponsor: VA Office of Research and Development | Trial completion date: Dec 2025 ➔ Mar 2029 | Trial primary completion date: Jul 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases. (PubMed, Int J Cancer) - "There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide-SCARs risk."

Journal • Eosinophilia • Immunology • Steven-Johnson Syndrome

Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC) (clinicaltrials.gov) - P1/2 | N=127 | Active, not recruiting | Sponsor: Aragon Pharmaceuticals, Inc. | Trial completion date: Dec 2027 ➔ Sep 2025

Trial completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world data explores benefits of apalutamide in metastatic hormone-sensitive #ProstateCancer. @maughanonc @huntsmancancer joins @zklaassen_md @GACancerCenter to talk about the #OASIS project, examining real-world outcomes with first-line apalutamide treatment in #mHSPC. #WatchNow > http://bit.ly/43YDcbd

Johnson & Johnson Lifts Annual Forecast After Strong Cancer Drugs, Medtech Performance (Benzinga) - "The pharmaceutical giant reported sales of $23.74 billion, up 5.8% year over year and beating the consensus of $22.85 billion. Operational growth was 4.6%, and adjusted operational growth was 3%...Erleada (apalutamide), Rybrevant/Lazcluze in oncology...Cancer sales increased to $6.31 billion, up 24% (+22.3% operational)."

Sales • Hormone Sensitive Prostate Cancer • Non Small Cell Lung Cancer • Prostate Cancer

A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=1300 | Not yet recruiting | Sponsor: Pfizer

New trial • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Prospective study of endogenous testosterone recovery following neoadjuvant hormonal blockade and radical prostatectomy in high-risk prostate cancer patients. (PubMed, J Sex Med) - "After 3 months of neoadjuvant triple ADT and RP, significant recovery to non-castrate and normal T levels is seen in most patients by 1 year; yet, BTB recovery is achieved in only a third. Higher baseline T and younger age predict faster T normalization and BTB recovery, respectively."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Promomed launches first domestic generic of apalutamide for prostate cancer treatment (GxP News) - "Promomed has announced the launch of Apalutamide-Promomed (apalutamide), the first domestic second-generation androgen receptor inhibitor used to treat both metastatic hormone-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer...Earlier, the Federal Antimonopoly Service (FAS) of Russia approved the price of the Russian drug Apalutamide-Promomed. The price of a 60 mg tablet is set at 659 rubles, which is 40% lower than the original drug, Erleada (Janssen), priced at 1,176 rubles per tablet."

Generic launch • Pricing • Castration-Resistant Prostate Cancer • Hormone Sensitive Prostate Cancer

NOVEL ANDROGEN RECEPTOR INHIBITORS IN PROSTATE CANCER: WHAT DO WE KNOW SO FAR? (PubMed, Crit Rev Oncol Hematol) - " We conducted a research from Pubmed and Embase database regarding the terms 'prostate cancer', 'ARSI', 'androgen receptor inhibitors', ''enzalutamide", "apalutamide", and "Darolutamide". Based on this research 185 potentially relevant articles were found, limiting our research to the period 2019-2025 of publication. 75 articles were excluded on the basis of abstract, title or the content."

Journal • Review • Genito-urinary Cancer • Lung Cancer • Oncology • Prostate Cancer • Solid Tumor

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019-2023). (PubMed, J Med Econ) - "While linkages between the data sources are comprehensive, any mis-linkages may have led to misclassification and information bias. The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide."

HEOR • Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

LIBERTAS: A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (clinicaltrials.gov) - P3 | N=420 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Aug 2026 | Trial primary completion date: Jan 2027 ➔ Aug 2026

Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

TMPRSS2 Expression in Lung Tissue of Prostatic Adenocarcinoma Patients: A Pathologic Perspective on Androgen Deprivation Therapy. (PubMed, medRxiv) - "Direct AR antagonists (apalutamide, bicalutamide) produced more pronounced TMPRSS2 suppression than GnRH modulators or androgen biosynthesis inhibitors. Our findings demonstrate that ADT significantly reduces pulmonary TMPRSS2 expression, with direct AR antagonists showing the strongest effect. This suggests a potential mechanistic explanation for differential COVID-19 susceptibility and provides rationale for investigating AR-targeted therapies as potential protective interventions against SARS-CoV-2 infection severity."

Journal • Genito-urinary Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Respiratory Diseases • Solid Tumor • AR • TMPRSS2

Phenotypic Plasticity and Androgen Receptor Bypass Drive Cross-Resistance to Apalutamide in Castration-Resistant Prostate Cancer Cell Models. (PubMed, Int J Mol Sci) - "The treatment of choice for prostate cancer is androgen deprivation (ADT) and novel hormonal agents such as Abiraterone, Enzalutamide, or Apalutamide. Most CRPC cell models developed cross-resistance to Apalutamide and were able to proliferate and retain their clonogenic capability. Apalutamide resistance was not linked to the expression of AR-V7 or AR-V9 variants but was instead associated to bypass of AR signaling pathway and the emergence of more aggressive expression profiles."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Apalutamide and Stereotactic Body Radiotherapy in Metastatic Hormone-Sensitive Prostate Cancer: Multicenter Real-World Study. (PubMed, Cancers (Basel)) - "The combination of apalutamide and SBRT in mHSPC is associated with high local and systemic disease control and minimal toxicity in a real-world setting. This approach may delay systemic treatment intensification and the onset of castration resistance. Prospective studies are warranted to confirm these findings."

Journal • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor