CHMP recommends extension of indication of Zytiga (abiraterone) in prostate cancer.- Janssen-Cilag.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Zytiga (abiraterone) from Janssen-Cilag, in prostate cancer. The CHMP adopted an extension to the existing indication as follows: “Zytiga is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

The full indication now reads: “Zytiga is indicated with prednisone or prednisolone for: • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.”

Comment: Recent results from the pivotal 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, respectively) in patients with mHNPC. Additional study results found patients 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 end points, 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.