The FDA has approved Bristol-Myers Squibb's Yervoy (ipilimumab), a closely-watched new drug for advanced melanoma. The FDA delayed a decision on the drug in November after BMS submitted further analysis of melanoma data at the FDA's request; additional time was needed to review the BLA.
The drug approval is a rare win in the field of melanoma, which has experienced more than its fair share of new drug failures. Melanoma that has spread to other organs is notoriously difficult to treat, leaving patients with few options. Researchers observed higher one- and two-year survival rates for patients on Yervoy, and although ipilimumab is linked to some severe side effects--including colon inflammation, diarrhea and skin rashes and even death--the dearth of options for advanced-stage melanoma patients prompted the agency to approve the drug.
Yervoy won't come cheap. According to Bloomberg, the groundbreaking treatment will cost a hefty $30,000 per dose and up to $120,000 for four courses of treatment. The drug could hit peak sales of $1.7 billion per year by 2015, analysts Tim Anderson of Sanford C. Bernstein tells the news service, and account for 10 percent of the drugmaker's sales. The therapy is also being explored as a treatment for prostate and lung cancer.
- read the Bloomberg report
Special Report: Ipilimumab: Timeline of a melanoma drug