U.K. drug reviewers slam BMS' melanoma blockbuster but bless J&J's diabetes pill

Courtesy of Bristol-Myers Squibb

Britain's National Institute for Health and Care Excellence (NICE) has struck yet another blow against costly cancer drugs. The cost-effectiveness agency recommended that Bristol-Myers Squibb's ($BMY) widely embraced Yervoy (ipilimumab) should not be used as a first-line treatment for melanoma. The agency does recommend the drug for second-line treatment, but says BMS needs to do more clinical trials to prove its "clinical effectiveness" for earlier use.

It seems NICE's main gripe with BMS is that the company provided clinical trial data for Yervoy at a dose of 10 mg/kg, which is larger than the actual licensed dose. "The Committee concluded that although it was not implausible that the absolute effect of first- and second-line ipilimumab treatment could be similar, there was no robust evidence available that the licensed dose of 3 mg/kg would have the same effectiveness as 10 mg/kg," according to the NICE guidance document.

NICE's ruling effectively restricts access to Yervoy in the U.K. to patients who are participating in clinical trials or who have failed other therapies--an unwise move, says BMS. "This decision could leave [patients] without the option to be treated with this innovative immuno-oncology therapy which has the potential to offer long-term survival," BMS said in a statement obtained by Pharmafile.

The decision marked a rare setback for Yervoy, which hit the market in 2011 and quickly took off. The drug brought in sales of $960 million in 2013--a 36% jump over the previous year. And BMS continues to churn out data proving Yervoy's value to patients: Last September, the company reported that 22% of participants in a long-term trial were still alive after three years, and some patients were charting a decade of additional survival thanks to the drug.

NICE is accepting comments on its Yervoy decision now and expects to make its final decision in June.

The British drug-review agency was much kinder to Johnson & Johnson's ($JNJ) new diabetes drug Invokana (canagliflozin), recommending it for patients with the Type 2 form of the disease. Invokana hit the market last spring as one of the first in a class of drugs known as SGLT2 inhibitors, which help the body clear sugar from the blood by blocking a protein involved in glucose reabsorption.

- access the NICE guidance on Yervoy
- here's the Pharmafile story on Yervoy
- read more at PharmaTimes
- read NICE's statement on Invokana
- read Bristol-Myers Squibb's statement

Special Report: Top 15 Drug Launch Superstars - Yervoy, Bristol-Myers Squibb