Wednesday, 1 June 2011

Pfizer seeking European approval on one of its top cancer prospects

With Pfizer investigators preparing to go into some detail at ASCO to make their case for axitinib as a treatment for late-stage kidney cancer, its regulatory team has pushed ahead with an application for marketing approval in Europe.
The development trajectory for axitinib has been marked by some serious setbacks, including its failure in a 2009 late-stage study for pancreatic cancer. But just weeks ago Pfizer, which badly needs to prove that it can seek and gain approvals on important new drugs, reported that axitinib beat Nexavar on progression-free survival of advanced kidney cancer, delaying tumor progression by an average of two months. Patients went an average of 6.7 months without tumor progression after taking axitinib compared to 4.7 months in the Nexavar arm.
That successful late-stage study set the stage for Pfizer to begin filing for approval around the world. "We hope that axitinib will be approved as an additional therapeutic option for patients with advanced RCC, alongside Pfizer's two medications approved in this disease, Sutent and Torisel," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, at the time.

"While the prognosis for patients with advanced RCC has improved dramatically over the past five years thanks to the availability of new treatments, there is still a need for new options in this patient population," said Garry Nicholson, president and general manager of Pfizer's oncology business unit. Axitinib is also in a mid-stage study for hepatocellular carcinoma. Pfizer will discuss the Phase III kidney cancer study on June 6 at ASCO.

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