Genentech has filed for approval in the USA for vismodegib, its candidate drug for a form of skin cancer known as basal cell carcinoma (BCC).
The Roche unit is seeking a green light to sell vismodegib for advanced BCC patients whose tumours are not suitable for surgery on the strength of the Phase II ERIVANCE BCC trial, which showed that the drug shrank tumours or healed visible lesions, with overall response rates of 43% of patients in patients with locally advanced BCC cohort and 30% of those with metastatic disease.
With around 2 million new cases every year, BCC is the most common cancer in the US and the most common type of skin cancer and is curable using surgery in the early stages. In more advanced cases the prognosis is less good, with a risk of disfigurement, disability and death, and to date there are no drugs specifically approved to treat the disease.
Vismodegib is a first-in-class investigational, oral medicine that works by selectively inhibiting signaling in the Hedgehog pathway, which is implicated in more than 90% of BCC cases.
The filing will lead to an $8 million milestone payment for vismodegib's originator, US biotech company Curis - provided the FDA accepts it for review.
Roche will be hoping it has more luck getting approval for vismodegib on the strength of a single Phase II trial than it did when it filed its antibody conjugate trastuzumab-DM1 as a treatment for breast cancer. That dossier was not accepted for review by the FDA, and the drug is now in a Phase III trials programme, with a re-submission not expected until the middle of next year.
The Swiss drugmaker said that the timing of a European regulatory submission is subject to ongoing discussions with the European Medicines Agency.