Janssen’s cancer drug Zytiga receives CHMP recommendation

Janssen has been granted a recommendation from the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency for approval of the prostate cancer drug Zytiga.

The oral, once-daily medication has been endorsed for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer patients who have not benefited from androgen-deprivation therapy or chemotherapy.

Data from the phase III COU-AA-302 study showed that the drug is able to deliver statistically significant improvements in radiographic progression-free survival rates.

It is thought that Zytiga can help prostate cancer patients to live longer, delay the need for chemotherapy and improve their quality of life.

Jane Griffiths, group chairman for Janssen's Europe, Middle East and Africa division, said: "This positive opinion brings us a step closer to being able to offer Zytiga to advanced cancer patients earlier in the course of their disease and fills a previously unmet medical need."

Earlier this month, the company reported positive data from the phase III Psummit trial, which demonstrated the efficacy of its psoriatic arthritis therapy Stelara.