Zelboraf approved for melanoma with BRAF mutations

What's exciting about Zelboraf?

Roche’s new drug Zelboraf (also known as PLX4032 and vemurafenib) was approved by the FDA on August 17th 2011 for treatment of melanoma patients whose tumors have BRAF mutations. Now that the drug has been approved, your doctor can prescribe it after determining that your tumor has this mutation.

In clinical trials with Zelboraf, patients' tumors stopped growing for several months and patients were 63% less likely to die during the trial, as compared to those receiving chemotherapy. (Use the Targeted Therapy Finder tool to see if Zelboraf may be right for you.)

What are its side effects?

The most common side effects include joint pain, skin rashes, and photosensitivity. Nausea, diarrhea, fatigue, hair loss, and cutaneous squamous-cell carcinoma were also observed. Patients that develop squamous cell carcinoma as a side effect of Zelboraf are treated by surgery and can continue with treatment (see drug label).

How can I get access to Zelboraf?

With Zelboraf's approval, your doctor can now prescribe this drug for you if your tumor has the BRAF mutation. To test the tumor, your doctor would order a laboratory test.

Several clinical trials are testing whether a combination of Zelboraf with other drugs might work better than Zelboraf alone. One exciting clinical trial combines Zelboraf with Yervoy, a new immunotherapy drug (read more about this trial). The table below lists several of these clinical trials, and by clicking on the name of a trial you can learn more about the drug used and the types of patients that the trial is looking for.