Roche and partner Curis are celebrating after getting the green light for Erivedge, their treatment for basal cell carcinoma, the most common type of skin cancer.
Erivedge (vismodegib), a once-a-day pill, is the first treatment for BCC to be approved by the US Food and Drug Administration. The approval comes after a priority (six-month) review and is based on results from a Phase II study that showed Erivedge shrank lesions in 27 of 63 patients with locally advanced BCC and 10 out of 33 patients with metastatic BCC.
The approval comes six weeks ahead of the original action date (March 8) for the drug, which selectively inhibits abnormal signalling in the Hedgehog pathway, "which is implicated in more than 90% of BCC cases," Roche notes. Chief medical officer Hal Barron noted that until now people with advanced BCC "had no approved medicines to help shrink disfiguring or potentially life-threatening lesions".
He added that "we are pleased that in the last six months we have been able to provide two new medicines for different types of advanced skin cancer to people who previously had few or no treatment options", referring to the melanoma drug Zelboraf (vemurafenib), approved by the FDA in August.
The approval, which also comes with a boxed warning of the potential risk of death or severe birth defects to unborn babies, triggers a $10 million payment to Curis. Erivedge will cost $7,500 per month and the duration of treatment per patient is expected be around 10 months.
Simos Simeonidis and Yatin Suneja, analysts at Cowen & Co, issued a research note saying they expect 2015 sales, including Europe where they predict a launch in 2013, of $401 million, with peak 2022 sales of $533 million, resulting in royalties to Curis of $32 million and $43 million, respectively.