safety concerns

This was an impressive week for the Food and Drug Administration and cancer treatment. The feds gave cancer breakthrough status to an extraordinary number of therapies for hard-to-treat malignancies.

Poliovirus vs. Glioblastoma Brain Cancer:

On Sunday (May 15, 2016) 60 Minutes announced that the FDA has just granted cancer breakthrough status to a specially modified poliovirus to treat glioblastoma. This is a deadly brain cancer with a terrible prognosis. CBS was granted special access to the research team and glioblastoma patients at Duke Medicine over the last two years.

During this Phase 1 proof-of-concept phase, the researchers administered their engineered poliovirus directly into the brains of 38 patients. The poliovirus was designed to attack the tumor but not to infect the rest of the brain. At the end of this stage, patients were living on average 15 months, which is five months longer than expected. Three patients were declared disease-free after three years, a truly extraordinary outcome.

Because these results appear so promising, the FDA has given Duke the green light to move forward with a Phase 2 trial under the breakthrough designation. That means 40 other institutions will be able to recruit hundreds of glioblastoma patients around the country. If the results of this Phase 2 trial remain favorable, the FDA is likely to approve super fast-track status to the modified poliovirus so that Duke will be able to supply this therapy to medical centers around the country without going through the usual Phase 3 trial process. To learn more about this fascinating story, check out this link to the 60 Minutes story “BREAKTHROUGH STATUS.”

Tecentriq (atezolizumab) vs. Bladder Cancer:

On May 18, 2016, the FDA approved Tecentriq for advanced cases of bladder cancer (urothelial carcinoma). It too received FDA’s label of cancer breakthrough therapy.” This immunotherapy was reserved for patients who had no longer responded to traditional chemotherapy.

According to the head of immunotherapy research at Genentech, these patients normally have a lifespan of six months once chemo loses its effectiveness. With Tecentriq on board, some lived up to three years longer. More details on Tecentriq are available at the FDA’s website.

VYXEOS (cytarabine:daunorubicin, also known as CPX-351) vs. Acute Myeloid Leukemia:

Acute myeloid leukemia (AML) is the most common type of leukemia in adults. This drug that FDA designated as a cancer breakthrough drug is really a combination of two older chemotherapy medications, cytarabine and daunorubicin. They are combined into nano-scale liposomes to act synergistically against high-risk AML.

The most recent study shows that people who received VYXEOS had better overall survival, which is of course what cancer patients care about. Half of those on standard chemo survived for 6 months or less. In comparison, half of the patients given VYXEOS lived at least 9.5 months. More importantly, after two years almost one-third of the patients getting VYXEOS were still alive, compared to 12 percent of those on standard chemo.

Keytruda (pembrolizumab) for Melanoma & More:

Keytruda is an important advance in the treatment of malignant melanoma. It is the drug that Jimmy Carter received and has had an important impact on his disease. He is currently considered cancer free.

At the annual meeting of clinical oncologists (ASCO) it will be announced that Keytruda has extended disease-free survival for 40 percent of patients up to three years. Standard treatment would accomplish this for only about 5 percent of patients.

This immunotherapy has just received cancer breakthrough status designation from the FDA for the treatment of Classical Hodgkin Lymphoma (cHL). That is in addition to advanced melanoma, colorectal cancer and non-small cell lung cancer.

What Does FDA’s ” Cancer Breakthrough Status” Mean?

First, it does not necessarily mean what many patients would hope. Breakthrough does NOT mean cure. Although some patients have achieved long-lasting benefits, like the three glioblastoma patients in the Duke Phase 1 trial, many only “buy” a few months extra survival time. That can be quite meaningful, but it can also be incredibly expensive. Many of these new immunotherapy treatments cost over $10,000 per month.

Advances in cancer are coming faster (as this week demonstrates). But we are still far from really long-lasting, reliable cancer treatments for most patients. And side effects can be serious, even with some of the highly praised new therapies. The bottom line seems to be that we have a long way to go before researchers can claim a true cancer cure for many hard-to-treat malignancies.

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  1. Elisa Kits

    Top work. I have been in health and medical research for the last 25 years and it is the most rewarding job, knowing that you work so so hard and when you get the results the feeling is immense! Keep up the great work guys!

  2. Drew

    What amazing therapies they have created at Duke University. I had wanted to get my sister there for her brain cancer in 2011 an had talked with Dr. Friedman but she developed pneumonia and died. Unfortunately I lost another sibling to this same dread disease…

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