Vismodegib, a new skin cancer drug for patients with advanced basal cell carcinoma used for the first time in the world at the Virginia G. Piper Cancer Center at Scottsdale Healthcare, is hailed as “the greatest advance in therapy yet seen” for advanced basal cell carcinoma in an editorial in today’s New England Journal of Medicine.
Vismodegib (Erivedge) was administered for the first time in the world Jan. 23, 2007 in a phase I clinical trial at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with the Translational Genomics Research Institute (TGen). Vismodegib received FDA approval on Jan. 30, 2012.
The successful Phase I study at Virginia G. Piper Cancer Center Clinical Trials led to the broader follow-up study, which validated the researchers’ work and was published in the current New England Journal of Medicine. The drug blocks the Hedgehog signaling pathway and was approved for treatment of locally advanced and metastatic basal cell carcinomas. Additional research noted encouraging results for patients with basal cell nevus syndrome.
“It is a landmark day for patients with basal cell carcinoma and all those involved in their care,” said the NEJM editorial. However the editors cautioned that additional study of Hedgehog pathway inhibitors like Vismodegib warrant further study so a larger number of patients may benefit.
The drug is the first to receive FDA approval to treat inoperable basal cell carcinoma. Successful early trial results led to a broader subsequent study sponsored by Genentech. The drug is being marketed under the name Erivedge.
This is the first drug tested under the Scottsdale Healthcare-TGen partnership to receive FDA approval.
FDA approval in five years is a remarkable achievement because clinical trials progress through three phases and can take up to 15 years or more to successfully complete, according to Mark Slater, PhD, vice president of research at Scottsdale Healthcare.
“The first patient put on this drug had advanced basal cell cancer, so we suspected that the tumor had the mutation this drug is targeted against,” said Ramesh K. Ramanathan, MD, medical director at Virginia G. Piper Cancer Center Clinical Trials. “And our partnership with Dr. Ronald Korn and his team who did advanced PET imaging helped to really demonstrate the drug's efficacy for Genentech to continue pursuing the additional study.”
Most instances of basal cell cancer can be effectively treated, but in some cases, the cancer cells spread and develop an aggressive form of the cancer that does not respond to standard surgical treatment.
“In some patients there is progression to life-threatening, locally advanced or metastatic tumors. Approved as a pill to be taken once a day, we believe this new drug represents an opportunity to improve quality of life for these patients,” said Glen Weiss, MD, director of Thoracic Oncology at Virginia G. Piper Cancer Center Clinical Trials and assistant professor of TGen’s Cancer and Cell Biology Division.
San Francisco-based Genentech developed Vismodegib. Successful results of early clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Johns Hopkins University and Karmanos Cancer Institute were published in the Sept. 17, 2009 New England Journal of Medicine and led to interest in increased access to the drug.
Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at 480-323-1339; toll free at 1-877-273-3713 or via email at firstname.lastname@example.org.
Public Relations Director, Virginia G. Piper Cancer Center