Takeda Has One Shot Remaining With Orteronel In Prostate Cancer
This article was originally published in Pharmaceutical Approvals Monthly
Phase III ELM-PC 5 study of orteronel in post-chemo metastatic castration-resistant prostate cancer is unblinded after drug fails to improve overall survival. But the company is continuing a Phase III trial in an earlier line of therapy.
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The non-steroidal androgen synthesis inhibitor failed to show a survival benefit in chemotherapy-naïve prostate cancer patients after also failing in post-chemo patients in 2013. With Takeda ending development of the Phase III candidate, its Millennium cancer pipeline is reduced to a pair of Phase III candidates.
The most recent events in the fast-evolving castration-resistant prostate cancer field illustrate how the major advances in therapy for patients who failed chemotherapy are now spreading to the larger population of CRPC patients receiving first-line therapy for metastatic disease. The upcoming year should see Phase III results from candidates ranging from a kinase inhibitor to an antisense agent.
FDA approval of Zytiga in the pre-chemo setting gives the androgen blocker a second prostate cancer indication and another revenue stream – but a short remaining patent life and a significant competitive threat may mitigate the achievement.