Monthly Archives: September 2020

FDA approves pembrolizumab for BCG-unresponsive, high-risk non-muscle invasive bladder cancer.

Comments – another drug option for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Kindly note this is for SUPERFICIAL (non-muscle-invasive) bladder cancers. Muscle-invasive bladder cancers will still […]

PARP Inhibitor Prolongs Overall Survival in mCRPC

Comments: Olaparib increases overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had tumors with at least 1 alteration in BRCA1, BRCA2, or ATMgenes, according to a final analysis of the PROfound trial. Do note that On May 19, 2020, the FDA approved olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) for adult patients with […]

Darolutamide survival benefit in prostate cancer highlighted in NEJM

Comments: Final overall survival data (OS) from the phase 3 ARAMIS trial showed that adding darolutamide (Nubeqa) to androgen deprivation therapy (ADT) led to a 31% reduction in the risk of death compared with ADT alone in patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to results published in the New England Journal of Medicine. […]

Nivolumab Plus Cabozantinib Improves OS in CheckMate-9ER Frontline RCC Trial

 “The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients” Median progression free survival among patients with advanced RCC (Renal Cell Cancer), which was the trial’s primary […]

Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer

Comments: The HERO trial is an international, multicenter study comparing Relugolix (an oral androgen deprivation therapy agent given 120 mg orally, once daily) to leuprolide (22.5 mg injection, every 3 months) for 48 weeks. The primary end point of the study was the sustained suppression of testosterone to castrate levels, defined as testosterone less than […]

Rucaparib pharmacokinetic analyses support use in mCRPC

Comments: The US Food & Drug Administration on May 15, 2020, granted accelerated approval for the oral PARP inhibitor rucaparib for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic mCRPC who have been treated with androgen receptor (AR)–directed therapy and a taxane-based chemotherapy , based on objective tumor and prostate-specific antigen (PSA) […]

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