FDA finally approves drug for BC

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WASHINGTON — The Food and Drug Administration has approved a first-of-a-kind breast-cancer medication that targets tumor cells while sparing healthy ones.



The drug Kadcyla from Roche combines the established drug Herceptin with a powerful chemotherapy drug and a third chemical linking the medicines together. The chemical keeps the cocktail intact until it binds to a cancer cell, delivering a potent dose of anti-tumor poison.



Cancer researchers say the drug is an important step forward because it delivers more medication while reducing the unpleasant side effects of chemotherapy.



"This antibody goes seeking out the tumor cells, gets internalized and then explodes them from within. So it's very kind and gentle on the patients — there's no hair loss, no nausea, no vomiting," said Dr. Melody Cobleigh of Rush University Medical Center. "It's a revolutionary way of treating cancer."



Cobleigh helped conduct the key studies of the drug at the Chicago facility.



The FDA approved the new treatment for about 20 percent of breast-cancer patients with a form of the disease that is typically more aggressive and less responsive to hormone therapy. These patients have tumors that overproduce a protein known as HER-2.



Breast cancer is the second-most deadly form of cancer in U.S. women and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute.



The approval will help Roche's Genentech unit build on the blockbuster success of Herceptin, which has long dominated the breast-cancer marketplace. The drug had sales of roughly $6 billion last year.



Genentech said Friday that Kadcyla will cost $9,800 per month, compared with $4,500 per month for regular Herceptin. The company estimates a full course of Kadcyla, about nine months of medicine, will cost $94,000.



FDA scientists said they approved the drug based on company studies showing Kadcyla delayed the progression of breast cancer by several months. Researchers reported last year that patients treated with the drug lived 9.6 months before death or the spread of their disease, compared with a little more than six months for patients treated with two other standard drugs, Tykerb and Xeloda.



Overall, patients taking Kadcyla lived about 2.6 years, compared with 2 years for patients taking the other drugs.

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According to comments given from experts to Medscape Medical News (MMN), there is concern and frustration that this new drug is very expensive, leading to speculation that there will be a backlash against it, as there was with Zaltrap (aflibercept). The Memorial Sloan-Kettering Cancer Center very publicly refused to use Zaltrap because it was much more expensive than another approved drug for the treatment of colorectal cancer, which had similar efficacy.

Dr. Ann Partridge, from the Dana-Farber Cancer Institute and Harvard Medical School, told MMN that "all of these drugs are very expensive, making it difficult for some patients to get them even when they are approved and available." All four of the targeted therapies approved by the FDA for the treatment of HER2-positive metastatic breast cancer come with a high price tag. Drug prices seem to be set at the estimated maximum the market will bear.

Private practitioner Dr. Steven Vogl told MMN that the data on Kadcyla (T-DM1) are not as clear as they should be. The study's control regimen (Tykerb and Xeloda) was "distinctly suboptimal" and not a standard of care, even though it is an FDA-approved treatment option in this setting. The 5.8 month difference in overall survival in the two study groups might have been inflated by this control regimen. He would have preferred to see the control patients also receive Herceptin, which he believes to be a necessary complement to Tykerb.

He goes on to say that Kadcyla (T-DM1) does not meet the goals of a major advance, explaining that such an advance, in his opinion, must cure some patients, increase the rate of clinical complete remission, or produce a high rate of very long partial response.

This all should remind physicians that it is the good outcome of the patient not the therapy applied that constitute successful application of the healing arts. We must remember that the best medical care is not always the most expensive. We can still hope for a good outcome if you use all the available drugs at our disposal that best meet the needs of the patient.

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