Explore News By Topic

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

05/26/2017

FDA approves first precision medicine for the treatment of cancers with certain genetic defects, including prostate cancer

On May 23, 2017, the field of precision medicine achieved a major milestone with the FDA’s first ever approval of a cancer therapy based entirely on a tumor’s unique characteristics and not where the tumor developed in the body.  In other words, while therapies to date have been approved for... Read More