This was an awesome way to the Food and Drug Administration and cancer treatment week. The feds gave the progress of cancer to an extraordinary number of therapies for difficult cancers to treat.
Poliovirus against glioblastoma brain cancer
On Sunday (May 15, 2016) 60 minutes announced that the FDA recently granted the progress of cancer poliovirus specially modified to treat glioblastoma. This is a deadly brain cancer with a terrible prognosis. CBS was granted special access to glioblastoma patients and research team at Duke Medicine in the last two years.
During this phase of the Phase 1 proof of concept, the researchers administered its engineering poliovirus directly into the brain of 38 patients. The poliovirus is designed to attack the tumor but not to infect the rest of the brain. At the end of this stage, patients lived an average of 15 months, which is five months longer than expected. Three patients were found after three years, a truly extraordinary result free of disease.
Because these results seem so promising, the FDA has given Duke green light to move forward with a Phase 2 trial with forward designation. That means 40 other institutions will be able to recruit hundreds of patients with glioblastoma across the country. If the results of this phase 2 study remain favorable, the FDA is likely superstate fast track to the modified Duke will be able to provide this therapy to medical centers around the country without polio virus approval go through the usual Phase 3 trial process. To learn more about this fascinating story, check out this link for 60 minutes history “ADVANCE STATE.”
Tecentriq (atezolizumab) against bladder cancer:
On May 18, 2016, the FDA approved Tecentriq for advanced cases of bladder cancer (urothelial carcinoma). He also received the label breakthrough cancer therapy FDA. “This immunotherapy is reserved for patients who had no longer responded to traditional chemotherapy.
According to the head of research of immunotherapy in Genentech, these patients usually have a shelf life of six months once chemotherapy loses its effectiveness with Tecentriq on board, some lived up to three years more details about Tecentriq are available on the website of the FDA
VYXEOS (cytarabine:… daunorubicin, also known as CPX-351) against acute myeloid leukemia
acute myeloid leukemia (AML) is the most common type of leukemia in adults This drug FDA designated as a breakthrough cancer drug really is. a combination of two drugs older chemotherapy, cytarabine and daunorubicin. combine liposome nano-scale to act synergistically against AML high risk.
the most recent study shows that people who received VYXEOS had better overall survival, which of course is what cancer patients care. Half of standard chemotherapy survived for 6 months or less. In comparison, half of the patients receiving VYXEOS lived at least 9.5 months. More importantly, after two years, nearly one-third of patients who received VYXEOS were still alive, compared with 12 percent of standard chemotherapy.
Keytruda (pembrolizumab) for Melanoma & More:
Keytruda is an important step in the treatment of malignant melanoma advance. It is the drug that Jimmy Carter received and has had a major impact on their illness. Today is considered cancer free.
At the annual meeting of clinical oncologists (ASCO), which will be announced that Keytruda has extended disease-free survival in 40 percent of patients up to three years. The standard treatment would achieve this only about 5 percent of patients.
This immunotherapy has been designated status only advance the FDA for treating cancer classical Hodgkin lymphoma (CHL). It is also advanced melanoma, colorectal cancer and non-small lung cancer cells say.
What does the FDA “State of breakthrough cancer” mean?
First, it does not necessarily mean that what many patients expect. Advancement does not mean cure. Although some patients have achieved long-term benefits, like the three glioblastoma patients in the Phase 1 Duke, many of them just “buy” a few months additional survival time. Which can be quite significant, but can also be very expensive. Many of these new immunotherapy treatments cost more than $ 10,000 per month.
Advances in cancer are coming faster (as evidenced this week). But we are still far from cancer, very durable reliable treatments for most patients. And the side effects can be serious, even with some of the highly praised new therapies. The conclusion seems to be that we have a long way to go before researchers can claim a real cure for cancer of many malignant tumors difficult to treat.