Janssen Pharmaceuticals has submitted a “Supplemental New Drug Application” to the U.S. FDA which could expand the label for their hormone drug Zytiga (abiraterone acetate). If approved, this application would expand the use of Zytiga to treat men with earlier stages of metastatic prostate cancer. The actual description of the earlier would include men with high-risk metastatic hormone naïve prostate cancer (mHNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC).

This filing is based on the results from the Pivotal LATITUDE Trial which Evaluated Zytiga in Combination with Prednisone and Androgen Deprivation Therapy (ADT/ hormone therapy).

At the last ASCO meeting, it was disclosed that the LATITUDE study showed Zytiga in combination with prednisone and ADT reduced the risk of death by 38 percent compared to placebo plus ADT (median OS not reached vs. 34.7 months in men with mHNPC).

Additional study results found men with mHSPC who received Zytiga in combination with prednisone and ADT had a 53 percent lower risk of radiographic progression or death, compared to placebo plus ADT (median rPFS 33.0 months vs. 14.8 months, respectively

Concerning the secondary endpoints, Zytiga in combination with prednisone and ADT reduced the risk of pain progression by 31 percent and skeletal-related events by 30 percent and reduced the risk of needing to start chemotherapy by 56 percent compared to placebo plus ADT.

Additional data, presented at ESMO, which just ended, demonstrated clinically meaningful and statistically significant improvements in patient-reported outcomes (PRO) in men with high-risk mHNPC who received Zytiga in combination with prednisone and ADT compared to placebo plus ADT alone.

Zytiga in combination with prednisone and ADT, significantly delayed the time to the health-related quality of life degradation by 15 percent and significantly delayed the time to worst fatigue intensity progression by 35 percent for men with mHNPC.

Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and Appendiceal Cancer a rare cancer.