US approval for Sanofi’s Jevtana
pharmafile | July 19, 2010 | News story | Sales and Marketing | Jevtana, Sanofi-Aventis, chemotherapy, prostate cancer
US regulators have approved Sanofi-Aventis’ chemotherapy agent Jevtana in combination with the steroid prednisone to treat men with prostate cancer.
The combination of Jevtana and prednisone is the first therapy to have shown a significant survival benefit for patients with metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen in this setting.
Hormone therapy is frequently the first treatment offered for mHRPC, but patients who no longer respond to hormone therapy often receive chemotherapy. However, some patients develop chemotherapy resistance, and their disease continues to progress.
Before Jevtana, no available second-line treatment options were proven to provide a survival benefit in mHRPC patients.
Debasish Roychowdhury, senior VP of global oncology at Sanofi-Aventis, said: “For many years, treatment of advanced hormone refractory prostate cancer after docetaxel-containing therapy has remained an unmet medical need.
“The ability to introduce Jevtana for this patient population is an important achievement for Sanofi-Aventis Oncology that exemplifies our deep commitment to bringing innovative new therapies to the cancer community.”
Jevtana in combination with prednisone was approved based on results from the phase III TROPIC clinical study. This involved 755 patients with mHRPC previously treated with a docetaxel-containing treatment regimen.
Median overall survival in the patients receiving Jevtana plus prednisone was just over 15 months compared to 12.7 months for patients receiving mitoxantrone plus prednisone.
Jevtana was reviewed under the FDA’s priority review programme, which offers an expedited six-month review for drugs that may offer major advances in treatment, or provide a treatment when no adequate therapy exists.
In a boost for Sanofi Jevtana received quicker than expected approval – the deadline for US regulator the FDA to make a decision deadline was not until 30 September 2010.
“Patients have few therapeutic options in this disease setting,” said Richard Pazdur, director of the Office of Oncology Drug Products, part of the FDA’s Center for Drug Evaluation and Research.
“FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
Oliver Sartor, Piltz Professor for cancer research at Tulane Medical School, New Orleans, and North American principal investigator for the pivotal TROPIC trial, said: “The prostate cancer community is thrilled to now have a new treatment option available for these patients whose disease is very difficult to treat.”
Sartor added: “Jevtana will help fill a critical treatment gap, since it is the first treatment approved for patients with this stage of metastatic hormone-refractory prostate cancer.”
Ben Adams
Related Content
First patient dosed in AdvanCell’s phase 1/2 trial for prostate cancer treatment
AdvanCell has announced that the first patient has been dosed with 212Pb-ADVC001 in its phase …
Lynparza granted approval to treat prostate cancer in Japan
AstraZeneca and Merck (known as MSD outside the US and Canada) have received approval from …
FDA approved Janssen’s Akeega for prostate cancer treatment
The Janssen Pharmaceutical companies of Johnson & Johnson have announced that the US Food and …
