Posted on Dec 27, 2014

The Food and Drug Administration just approved Bristol-Myers Squibb’s drug Opdivo to treat melanoma.

The clinical trial data was very strong, according to recent reports. In a trial of 120 patients without any other options, 32% of patients responded to the drug and about 1/3 of those experienced a response in more than six months.

It isn’t a surprise that this innovative drug was approved three months before the FDA’s PDUFA goal. Lately, the oncology division has not taken its fully allotted time to review drugs, especially those looking for accelerated approval based on limited-but-promising data.

Cancer is the one area where breakthrough therapy has lived up to its true potential to speed patient access to high impact drugs.

Experts, however, are unsure how Opdivo will compete with Merck’s Keytruda, which was approved earlier this year. Both drugs were created to target the same pathway, PD-1. PD-1 is an internal block that tells the immune system not to attack human cells. Tumors are made up of human cells; the PD-1 checkpoint blocks the ability of the immune system to attack the tumor cells.  A drug that disrupts that block allows the immune system to attack the tumor.

Figuring out which drug will be more effective is complicated by the limited clinical trial data. Although both drugs were approved, both were given accelerated approval therefore they show promise in treating a disease with a high medical need but still have to prove their worth in later clinical trials.

It is difficult to compare the two trials that were done since they may have enrolled patients with different severities o their diseases. In addition, since this is a last-line-of-defense treatment, there isn’t an active comparative drug and using a placebo would be unethical since the response rate should be 0%.


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Gerry Oginski
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NY Medical Malpractice & Personal Injury Trial Lawyer