FDA Approved Drugs

The following drugs have been approved since the year 2000 for the treatment of  multiple myeloma:

Revlimid (lenalidomide)

FDA approved June 2006

This drug treats a form of myelodysplastic syndromes. The medicine may help you not need blood transfusions. To get lenalidomide, you must be registered in the RevAssist™ program. Your healthcare provider will explain the program to you and have you sign an agreement form. You will only receive up to a 28 day supply of the medicine at one time. You will need a new prescription for each refill.

Thalomid (thalidomide)

FDA approved May 2006

Thalidomide causes severe, life-threatening birth defects or death to an unborn child and is only available under strict guidelines. Both women and men must commit to strict guidelines when receiving thalidomide. To receive thalidomide, you, your physician, and your pharmacy must be registered in the System for Thalidomide Education and Prescribing Safety (STEPS) Program. You may only receive up to a 28-day supply of thalidomide at a time, and you will need a new prescription for each refill. Your prescription must be filled within 7 days of your doctor's office visit.

Velcade (bortezomib)

FDA approved May 2003

This drug, given as an injection, a new treatment for multiple myeloma, a cancer of the bone marrow. FDA reviewed the application for this drug in less than four months. Velcade is the first in a new class of anticancer agents known as proteasome inhibitors.

Velcade was approved under the accelerated approval program. The program helps make promising products for serious or life threatening diseases available earlier in the development process by allowing approval to be based on a promising effect of the drug, such as tumor shrinkage, before there is actual evidence of improved survival or other clinical benefit. The drug’s commercial sponsor worked closely with FDA to define the studies that would be conducted.

Velcade is indicated for patients whose disease has relapsed after two prior treatments and who have demonstrated resistance to their last treatment.

FDA evaluated the safety and efficacy of Velcade based on a study of 202 patients who had received at least two prior therapies and demonstrated disease progression on their most recent therapy. Altogether, out of 188 patients evaluated for response, twenty eight percent showed a response to Velcade. The response lasted a median time of one year. Another trial in 54 patients with relapsed multiple myeloma showed similar responses.

As of yet there are no controlled trials of Velcade demonstrating clinical benefit, such as improvement in survival. To address this issue, Velcade’s developer will perform additional studies after approval. These will include the completion of an on-going study and an additional study comparing Velcade to standard therapy.

The most commonly reported adverse events reported in clinical trials include nausea, fatigue, diarrhea, constipation, headache, decreased appetite, decreased platelets and red cells in the blood, fever, vomiting, and peripheral neuropathy (numbness and tingling, and occasionally pain in the extremities.)

Zometa (zoledronate)

FDA approved February 2002

This drug reduces the release and breakdown of calcium from bone. It is used when you have a high amount of calcium in your blood to lower the blood calcium levels. High blood calcium levels can make you confused and tired and cause stomach pain and muscle weakness. Zoledronic acid helps to relieve these symptoms. Zoledronic acid is also used to prevent complications of cancer that has spread to the bone.