Immunotherapy drug for melanoma gets approved by US FDA
Immunotherapy drug for melanoma gets approved by US FDA
22 Dec 2014Metastatic or unresectable melanoma is an aggressive disease. Patients whose tumor is not responding to current drug therapies have another treatment option: the US FDA approved nivolumab (trade name: Opdivo), which fights cancer by working with the body's immune system.
32% of tumors shrunk by at least 50% in the trial
Approval was based on trial data from 120 patients evaluated for efficacy and 370 for safety.
In the efficacy studies, 32% of participants receiving nivolumab achieved objective responses (at least 50% shrinkage in tumor volume). The benefit lasted for more than 6 months in approximately one-third of the participants who experienced tumor shrinkage, the FDA said.
The drug works by blocking the so-called "programmed death-1" (PD-1) pathway.
Side effects from the treatment
Safety analyses indicated that the most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and edema.
The most serious side effects were severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys, and endocrine glands, according to the agency.
Accelerated approval granted
Nivolumab, to be sold by Bristol-Myers Squibb, was cleared under the FDA's accelerated approval program. Normally such approvals come with requirements for follow-up studies to confirm the clinical benefit, but the agency's announcement did not specify what they would be.
It is the 7th new agent to be approved for treating melanoma in the past 4 years, the FDA said in announcing the decision.
Source: MedPage Today