Benlysta, BMS melanoma drug win accelerated FDA review

Two of the most closely watched therapies now awaiting a final decision at the FDA won an accelerated regulatory review. Human Genome Sciences will have four months shaved off the usual review schedule for Benlysta, which could be the first new lupus drug to gain approval in half a century. The FDA has marked December 9th as its deadline on Benlysta. And Bristol-Myers Squibb has received a significant leg up in its quest to gain quick U.S. approval of ipilimumab for melanoma. The FDA has...

BMS, Pfizer cancer drugs take starring roles at ASCO

 Bristol-Myers Squibb's ipilimumab took the center ring at ASCO over the weekend, earning star billing for its promising data on melanoma. In a small trial, patients taking the drug lived a median of 10 months, compared to 6.4 months in a control group. And almost a quarter of the patients taking the therapy were alive after two years, compared to just 14 percent of the control group. "This is the first randomized placebo-controlled trial ever to show a survival benefit in Stage 4...

After lengthy delay, BMS plans starring ASCO role for melanoma drug

An experimental immunotherapy skin cancer drug from Bristol-Myers Squibb (NYSE: BMY) will get star treatment at the upcoming ASCO confab. Observers will get a close look at new data on ipilimumab, which has extended the lives of metastatic melanoma patients in three small clinical trials and may be up for an approval in 2011. "We have hundreds of patients who are still alive after taking this treatment, and that is something unheard of" in advanced-stage melanoma, Renzo Canetta,...