$JNJ files NDA for abiraterone in castration resistant prostate cancer
At the recent European Society of Medical Oncology (ESMO) meeting, J&J and Centocor OrthoBiotech announced that they planned to submit the filing for abiraterone by the year end, following the presentation of the phase III data by Johann de Bono from the Royal Marsden. That moment finally came today with a press release announcing the news within the last half hour or so.
The filing, in castration resistant prostate cancer (CRPC) after treatment with a taxane (such as docetaxel), has apparently taken place in both the EU and US. For men with the disease in the US, approval of this agent could come within six months or even less, but the EMA will likely take a little longer, as they do not have an official priority review process.
It’s mixed blessings for me – too late to help my Dad or my friends Fathers, but hopefully it will represent good news and a new option for other men in their situation who have advanced disease and are too frail for chemotherapy.
You can read more about the data from ESMO here.
{Hat Tip to my buddy @adamfeuerstein of The Street for alerting me promptly to the news}