European approval for prostate cancer drug Zytiga
pharmafile | September 8, 2011 | News story | Sales and Marketing | Janssen, Jevtana, Johnson & Johnson, Zytiga, prostate cancer
Johnson & Johnson’s Zytiga has been approved in the EU for late-stage prostate cancer.
Zytiga (abiraterone acetate) is now licenced as a second-line treatment, in combination with steroid prednisone for metastatic castration-resistant prostate cancer (mCRPC), in men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The drug is an androgen biosynthesis inhibitor, which blocks the production of testosterone, the hormone responsible for fuelling the cancer.
The simplicity of the once-a-day pill, and the absence of chemotherapy side effects means it should have an advantage over Sanofi’s new chemo drug Jevtana (cabazitaxel), which was approved for the same licence earlier this year.
Professor Karim Fizazi, Department of Cancer Medicine, Institut Gustave Roussy, France, an investigator in a pivotal phase III study, said: “The European Commission’s approval of abiraterone acetate gives new hope to men who are suffering from this late stage of prostate cancer with very few treatment options left.
“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain.”
The approval was based on trial results which showed Zytiga patients lived an average of 4.6 months longer than placebo patients (15.8 months compared with 11.2 months).
NICE has already begun its review of Zytiga, and is scheduled to complete its appraisal in May 2012.
The cost will not be announced until its European launch later this month, but it has a $40,000 (£25,000) price tag in the US for eight months of treatment, potentially putting it in a similar price bracket as Jevtana.
The drug was approved in the US in April, and is forecast to achieve global peak annual sales of $1 billion.
Growing market
Another challenger is Dendreon’s novel cancer vaccine Provenge, which gained a first-line licence in the US last year for asymptomatic or minimally symptomatic mCRPC.
Its $93,000 price tag and manufacturing problems have dogged Dendreon since its US launch in May last year, but it is still confident for a 2013 approval in Europe as a first-line treatment.
The drugs will compete in an expanding global market currently worth $1 billion, but is set to grow to $5 billion by 2015.
Ben Adams
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