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12/01/2020
UCLA, UCSF gain FDA approval for prostate cancer imaging technique
The University of California's two nationally ranked medical centers, UCSF and UCLA, and their nuclear medicine teams have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body... Read More
05/20/2020
Lynparza approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval by the US Food and Drug Administration... Read More
05/15/2020
Rubraca® (Rucaparib) Approved In The U.S. As Monotherapy Treatment For Patients With BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (MCRPC) Who Have Been Treated With Androgen Receptor-Directed Therapy And A Taxane-Based Chemotherapy
Rubraca is the first PARP inhibitor approved in a prostate cancer setting Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical trial i 44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in... Read More
12/16/2019
FDA approves enzalutamide for metastatic castration-sensitive prostate cancer
December 16, 2019 – Today the U.S. Food and Drug Administration (FDA) approved a new use for enzalutamide (Xtandi®) for the treatment of metastatic hormone-sensitive (aka, “castration-sensitive”) prostate cancer (mHSPC). Enzalutamide has previously been FDA-approved for the treatment of metastatic castration-resistant prostate cancer (mCRPC) and non-metastatic castration-resistant prostate cancer (nmCRPC). PCF funded... Read More
09/18/2019
FDA Approves Apalutamide (Erleada) for the treatment of metastatic hormone-sensitive prostate cancer
September 18, 2019 – Last night the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for the treatment of metastatic hormone-sensitive (aka, “castration-sensitive”) prostate cancer (mHSPC). Apalutamide has previously received FDA-approval for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). PCF funded the initial synthesis of apalutamide at UCLA... Read More
07/30/2019
FDA Approves Bayer’s Nubeqa® (darolutamide), a New Treatment for Men with Non-Metastatic Castration-Resistant Prostate Cancer
WHIPPANY, N.J., July 30, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation... Read More
10/02/2018
Clovis Oncology Receives Breakthrough Therapy Designation for Rubraca® (rucaparib) for Treatment of BRCA1/2-Mutated Metastatic Castration Resistant Prostate Cancer (mCRPC)
Breakthrough Therapy designation (BTD) granted to Rubraca based on initial data from ongoingTRITON2 Phase 2 study in advanced prostate cancer The data set from the TRITON2 study which supported BTD will be presented at the 2018 ESMO Congress later this month in Munich BOULDER, Colo. (BUSINESS WIRE) -- October... Read More
07/13/2018
FDA Approves Enzalutamide (Xtandi) for Non-Metastatic Castration-Resistant Prostate Cancer
July 13, 2018 – Today the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for the treatment of non-metastatic castration-resistant prostate cancer (non-metastatic CRPC). Non-metastatic CRPC is a clinical state in which PSA levels begin to rise in patients being treated with androgen deprivation therapy (ADT), but metastases are... Read More
02/14/2018
FDA Approves Apalutamide (Erleada); the first treatment for non-metastatic castration-resistant prostate cancer
February 14, 2018 – Today the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada, also previously called ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer (non-metastatic CRPC). This clinical setting is when men who are being treated with androgen deprivation therapy (ADT) see their PSA levels begin to... Read More
02/08/2018
FDA approves Abiraterone + Prednisone for Earlier Treatment of Metastatic Prostate Cancer
Back in June, we told you about the early results of the LATITUDE clinical trial, presented at the 2017 ASCO conference. The study indicated that giving abiraterone in combination with low-dose prednisone to men who were just starting ADT delayed cancer progression by an average of 18 months. The study... Read More