Combo Tx No Help After PSA Progression in mCRPC

Excerpt:

“Adding abiraterone acetate (Zytiga) to enzalutamide (Xtandi) did not improve progression-free survival (PFS) after prostate-specific antigen (PSA) progression in men on enzalutamide monotherapy for chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC), researchers found.

“In the randomized, double-blind PLATO trial, the median PFS in patients treated with enzalutamide plus abiraterone and prednisone was 5.7 months. By comparison, the PFS was 5.6 months in the control group treated with abiraterone and prednisone plus placebo (hazard ratio [HR] 0.83; P=0.22).”

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Low-Dose Abiraterone With Food vs Standard-Dose Abiraterone in Castration-Resistant Prostate Cancer

Excerpt:

“In a phase II trial reported in the Journal of Clinical Oncology, Szmulewitz et al found that low-dose abiraterone (Zytiga) given with a low-fat meal was noninferior to standard-dose abiraterone in the fasting state with regard to reduction in prostate-specific antigen (PSA) levels among patients with castration-resistant prostate cancer.”

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Taking a Standard Prostate Cancer Drug with Food Boosts Impact, Lowers Cost

Excerpt:

“By taking a high-cost drug with a low-fat meal — instead of on an empty stomach, as prescribed — prostate cancer patients could decrease their daily dose, prevent digestive issues and cut costs by 75 percent, according to a new study in the March 28, 2018, issue of the Journal of Clinical Oncology (JCO).

“Abiraterone acetate, marketed as Zytiga®, is the standard medicine used to treat metastatic castration-resistant prostate cancer. Patients taking Zytiga are told to take four of the 250 milligram pills first thing in the morning. Then, having gone without food overnight, they must wait at least one more hour before eating breakfast.”

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ZYTIGA® (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer

Excerpt:

“The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for ZYTIGA® (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC). The approval is based on Phase 3 data from the pivotal LATITUDE clinical trial, which found that in patients with metastatic high-risk CSPC, ZYTIGA® in combination with prednisone reduced the risk of death by 38 percent compared to placebos.”

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Janssen’s Zytiga Approved for Earlier Use in Prostate Cancer

Excerpt:

“European regulators are allowing earlier use of Janssen’s Zytiga in the treatment pathway for metastatic prostate cancer.

“Zytiga (abiraterone) plus prednisone/prednisolone has been approved to treat newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

“The drug is already available in Europe for metastatic castration-resistant prostate cancer (mCRPC) in adults who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated and in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.”

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Pivotal Role Remains With Bone-Targeting Agents in mCRPC

Excerpt:

“Prostate cancer researchers are continuing to explore strategies to optimally integrate bone-targeted agents into patient care.

“For example, an ongoing trial is assessing the combination of a radiopharmaceutical, radium-223 dichloride (Xofigo), with an androgen receptor-directed therapy, either abiraterone acetate (Zytiga) or enzalutamide (Xtandi). The open-label, phase IIa study is accruing patients with metastatic castration-resistant prostate cancer (mCRPC). The primary endpoint of the trial, which hopes to enroll 68 patients, is patient bone scan response rate (NCT02034552).”

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Pfizer’s Xtandi fails in progression trial vs. J&J’s Zytiga

Excerpt:

A late-stage trial found that continuing treatment with Pfizer Inc’s cancer drug Xtandi in addition to a regimen of Zytiga and a steroid worked no better than the two other drugs alone in patients with advanced prostate cancer whose disease had worsened, the company said on Wednesday.

“Zytiga, or abiraterone acetate, is sold by Johnson & Johnson.”

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Test Aids Prostate Cancer Treatment

Excerpt:

“Genomic Health Inc. has struck a deal to commercialize a new blood test that can help advanced prostate cancer patients decide whether to try costly new-generation drugs or rely on much cheaper traditional chemotherapy to improve their chances for survival.

“The test, developed by closely held Epic Sciences Inc., San Diego, detects a mutation associated with a poor response to two new drugs, Xtandi from Medivation Inc. and Astellas Pharma Inc. of Japan, and Zytiga from Johnson & Johnson.

“The two blockbuster drugs have significantly extended survival for many patients with advanced prostate cancer. But in a study published last month, patients who tested positive for the anomaly—a variant of the androgen receptor called AR-V7—lived substantially longer if they were treated with chemotherapy than those given the two new drugs. The receptor is the target of the new drugs.”

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Janssen's Zytiga Boosts Survival in Early-Stage Prostate Cancer

“Janssen has announced data from a post-hoc analysis of a Phase III trial showing that Zytiga plus prednisone boosted overall survival (OS) by 11.8 months compared with placebo plus prednisone, in men with early and less aggressive metastatic castration-resistant prostate cancer (mCRPC) who had not received chemotherapy.

“Data presented today at the European Association of Urology (EAU) 2016 Congress in Munich, Germany, demonstrated that in the COU-AA-302 trial, Zytiga (abiraterone acetate) increased OS to 53.6 months versus the 41.8 months achieved by patients treated with prednisone alone. This benefit was shown to be 4.4 greater than that previously reported for the combo in the final analysis of the COU-AA-302 trial in 2014.

“The post-hoc analysis divided patients into two groups to identify which group experienced a greater treatment benefit. The patients in group 1 were in an earlier, less advanced and less symptomatic stage of the disease, while those in group 2 were in a later, more advanced and more symptomatic stage of the disease.”