Immunotherapies Get FDA Approval

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Within just two weeks in November, the FDA approved two monoclonal-antibody drugs for multiple myeloma as blood cancers begin to move into the age of immune-system treatments. Myeloma is the second most common blood cancer, and it has a survival rate after five years of 45%. There are about 27,000 new cases each year in the United States, and about 11,000 people die every year from the cancer. About 90,000 people are living with the disease.

The new therapy is called elotuzumab, and it has been approved to be given with lenalidomide and dexamethasone, two older, more established chemotherapies for multiple myeloma that have been used as a combination for a decade. Cocktail approaches to cancer are becoming increasingly common as older therapies like lenalidomide have become part of the trials that help get newer drugs approved. Lenalidomide is chemically similar to Thalidomide, a drug originally prescribed in 1957 and given to pregnant women then. It caused horrible birth defects and thus Lenalidomide cannot be used by pregnant patients. Thalidomide-like drugs are also used to treat leprosy.

Daratumumab, the first monoclonal antibody for multiple myeloma, was approved in mid-November by the FDA two weeks before elotuzumab. Neither of the two new antibodies is approved as a first-line therapy. Patients are supposed to have tried at least three other therapies before turning to daratumumab. Elotuzumab cannot be taken unless the patient has tried at least one other therapy. It is thought to be an effective treatment for relapsed multiple myeloma patients.

Elotuzumab showed in a Phase 3 study that its effects grew over time, a phenomenon expected of immunotherapy drugs that train the immune system to respond to tissues that appear to it to be normal. The antibody puts a bull’s-eye on SLAMF7, a protein expressed by myeloma cells. At the same time, it bolsters the ability of natural killer cells to attack cells with SLAMF7.

Daratumumab produced significant responses — nearly 30% — in trial patients who had few if any other options left because their cancer had grown resistant to other therapies. It binds to cancer cells that express CD38, which is found on the surface of many white blood cells.

There are hundreds of immunotherapies working their way toward the FDA. The treatments are promising to revolutionize the fight against cancer and may be able to cure many cancers within a decade.

And if you think we’re still far away from immunotherapies becoming our first line of defense, you have only to consider the story of former president Jimmy Carter, who was struggling with a metastasis of melanoma in his brain — one of the most aggressive cancers known. After treatment with an immunotherapy, he appears to be cancer free.

To your health and wealth,

Stephen Petranek
for The Daily Reckoning

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The post Immunotherapies Get FDA Approval appeared first on Daily Reckoning.