Johnson & Johnson is celebrating a much earlier-than-expected FDA approval for Erlea, which becomes the first drug in the US for non-metastatic, castration-resistant prostate cancer (CRPC).
Erleada (apalutamide) – one of ten new drug candidates that J&J thinks could eventually make sales of more than $1bn a year – is also the first drug to be cleared on the strength of metastasis-free survival (MFS), a trial endpoint that has not been used before in any FDA approval of a cancer drug.
“In the trial supporting approval, Erleada had a robust effect on this endpoint,” said Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products. “This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public,” he added.
Around 10-20% of prostate cancer cases are castration-resistant, and up to 16% of these patients show no evidence that the cancer has spread at the time of the castration-resistant diagnosis, says the agency. In patients with non-metastatic CRPC, there is a high unmet need to delay development of metastases and the progression to advanced prostate cancer.
Erleada has been approved on the back of data from the SPARTAN study, which involved over 1,200 patients with non-metastatic CRPC who received either Erleada or placebo on top of hormone therapy with gonadotropin-releasing hormone (GnRH) analogues or with surgical castration. The median MFS for patients taking Erleada was 40.5 months compared to 16.2 months for the placebo arm.
The green light comes months ahead of the FDA’s target review date and is a big boost for J&J, which needs Erleada to hit the ground running and build momentum before Zytiga (abiraterone acetate) – its current blockbuster medicine for CRPC – faces generic competition in the US, which accounted for around half of the drug’s $2.5bn in sales in 2017.
That could occur later this year after J&J suffered a patent defeat last month, although the drug has patent protection outside the US until 2022.
It also gives J&J a leg-up in what looks set to be a big market tussle with Pfizer and Astellas and their Xtandi (enzalutamide) product, which has also been filed for approval in the US and EU for non-metastatic CRPC on the strength of MFS data from the PROSPER trial.
J&J acquired Erleada when it took over Aragon Pharma in 2013 in a deal valued at $1bn.