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

New indication for ZYTIGA® in combination with prednisone provides treatment option for patients with metastatic high-risk castration-sensitive prostate cancer

Findings from pivotal Phase 3 LATITUDE clinical trial data demonstrated statistically significant and clinically meaningful improvements in patients

HORSHAM, PA, USA I February 8, 2018 I 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.

"LATITUDE was a large global trial which produced impressive and clinically significant results in overall survival," said Karim Fizazi, M.D., Ph.D., Principal Investigator and Head of the Medical Oncology Department at Institute Gustave Roussy, Villejuif, France. "With today's approval, abiraterone acetate plus prednisone could become a standard of care for patients with metastatic high-risk castration-sensitive prostate cancer."

"Today's approval marks an important step in addressing the unmet needs of patients with metastatic high-risk castration-sensitive prostate cancer by providing an option that has demonstrated improvement in overall survival," said Andree Amelsberg, M.D., Vice President of Oncology Medical Affairs at Janssen Biotech, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. "This milestone is an exciting turning point for researchers and clinicians, and most importantly, for patients suffering from this disease and their families who now have an important additional therapeutic option."

LATITUDE was a multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial that examined the use of ZYTIGA® 1,000 mg once daily in combination with prednisone 5 mg once daily, compared to placebos (N=1,199) in patients with newly diagnosed, metastatic high-risk CSPC, who had not received prior cytotoxic chemotherapy.  All the patients received a gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. The study data were presented at the plenary session of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, and simultaneously published in The New England Journal of Medicine.1 The study showed ZYTIGA® in combination with prednisone reduced the risk of death by 38 percent compared to placebos (median OS not estimable vs. 34.7 months, respectively; hazard ratio (HR)=0.62; 95% confidence interval (CI): [0.51, 0.76], p<0.0001). Additional data demonstrated statistically significant delay in time to initiation of chemotherapy for patients in the ZYTIGA® arm compared to those in the placebo arm (median time to initiation of chemotherapy not reached vs. 38.9 months, respectively; HR=0.44; 95% CI: [0.35, 0.56], p < 0.0001).

The most common adverse reactions (≥10%) that occurred more commonly (>2%) in the ZYTIGA® arm from an analysis of pooled safety data were fatigue, arthralgia, hypertension, nausea, edema, hypokalemia, hot flush, diarrhea, vomiting, upper respiratory infection, cough and headache.

On November 20, 2017, the European Commission (EC) granted approval to broaden the marketing authorization for ZYTIGA® in combination with prednisone or prednisolone to include newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer (HSPC). Similar submissions have been made in Japan, Canada, Mexico, Switzerland, Singapore, and the Philippines, and approved in Brazil and Taiwan. If approved, these submissions will broaden the use of ZYTIGA® in combination with prednisone or prednisolone to include an earlier stage of prostate cancer than its current indications.

Metastatic prostate cancer is cancer that has spread to another part of the body.2 Metastatic castration-sensitive prostate cancer (CSPC), also referred to as metastatic hormone-sensitive prostate cancer (HSPC) in literature, refers to prostate cancer that still responds to testosterone suppression therapy.2 Patients with newly-diagnosed metastatic disease and high-risk disease characteristics tend to have a poorer prognosis.3

About the LATITUDE Clinical Trial4
The Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled LATITUDE study enrolled 1,199 patients with newly diagnosed metastatic, high-risk castration-sensitive prostate cancer (CSPC), who had not received prior cytotoxic chemotherapy. The study was conducted at 235 sites in 34 countries in Europe, Asia-Pacific, Latin America, and Canada. A total number of 597 patients were randomized to receive ZYTIGA® plus prednisone, while 602 patients were randomized to receive placebos. All patients received a gonadotropin-releasing hormone (GnRH) analog or had prior bilateral orchiectomy. High-risk disease was defined as having at least two of three risk factors at baseline: a total Gleason score of ≥8, presence of ≥3 lesions on bone scan, and evidence of measurable visceral metastases. Patients with significant cardiac, adrenal, or hepatic dysfunction were excluded. The median duration of treatment with ZYTIGA® and prednisone was 24 months.

About ZYTIGA®

ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients

  • with metastatic castration-resistant prostate cancer (CRPC)
  • with metastatic high-risk castration-sensitive prostate cancer (CSPC)

Since its first approval in the U.S. in 2011, ZYTIGA® has been approved in combination with prednisone or prednisolone, in 105 countries. More than 330,000 patients worldwide, including 113,000 in the U.S., have received treatment with it, and it was the number one prescribed oral medication in the U.S. for patients with metastatic CRPC in 2016.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

SOURCE: Janssen

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