Looks like (see below) the FDA has 'lowered the bar' and fast tracked Yervoy to approval on the basis of early trial 'proven survival' results to treat an unmet need (imo).
Therefore, one could reasonably argue that if Cvac achieves similar outcomes (or better) to that of Yervoy, in early stage 3 trials, Cvac may be fast tracked to commercialization in the States and Europe?
This second FDA approved immunotheraphy treatment, 'Yervoy' has had bad side effects - 13% severe to fatal! (check out www.yervoy.com)and yet still FDA approved!! ---- In comparison,Cvac has minimal toxicity/few side effects. ---- Check out the price for a standard regimen!! $$$ ---- "The U.S. Food and Drug Administration approved a new drug from Bristol-Myers Squibb Co. (BMY) to treat patients with metastatic or late-stage melanoma, the most deadly type of skin cancer.
The drug, ipilimumab, will be sold under the brand name Yervoy. Some analysts have predicted the product will eventually reach blockbuster status with sales topping $1 billion annually. The drug was approved for patients who have tried prior therapy as well as previously untreated patients--a wider patient population than originally expected.
"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," said Richard Pazdur, the director of the FDA's office of oncology drug products. "Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment."
Yervoy is designed to work by stimulating the body's immune system to fight cancer cells, part of an emerging approach to cancer treatment known as immunotherapy. The drug has shown promise in clinical trials. A study released last year showed Yervoy extended average overall survival to 10 months, versus nearly 6.5 months for patients on an experimental vaccine, in people who had tried prior treatments.
Bristol also said earlier this week the drug extended survival in a separate study among patients who had no prior treatment. Full results of the new study haven't been released but some data were shared with the FDA for its review. **** *****!
The drug shrank tumors in a small portion of patients who took it, and the average survival benefit may appear relatively modest. But some people who took the drug several years ago in early testing are still alive, doctors say.
"I think the vast majority of patients with metastatic melanoma should at some point try this agent," said Patrick Hwu, chairman of the department of melanoma medical oncology at the University of Texas MD Anderson Cancer Center in Houston.
The company plans to charge about $120,000 for a standard regimen of the Yervoy, higher than analysts' estimates. The drug is designed to be given in four infusions over three months. Bristol will charge $30,000 per infusion. Prices may vary because the dosage is dependent upon the weight of the patient.
Andreotti defended the high price, saying it was an innovative new treatment with a proven survival benefit for patients who don't have many current options. "There is a real value that is delivered from this drug," Andreotti said. Bristol also will provide financial assistance to people with trouble paying for it.
Yervoy does carry serious side effects including risks of fatal allergic reactions and will be sold under a so-called risk evaluation and mitigation strategy to inform health care professionals and patients about the risks.
The FDA said severe to fatal autoimmune reactions were seen in 12.9% of patients treated with Yervoy. Other side effects included fatigue, diarrhea, skin rash, endocrine deficiencies involving glands or hormones, and inflammation of the intestines."
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