Tuesday, April 5, 2011

FDA Approval for Ipilimumab!

The big news in the world of melanoma this month- or more realistically, this decade- is the FDA's approval of ipilimumab as the first drug ever to show significant benefits for metastatic melanoma patients:
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."

Truly fantastic news!

Incidentally, this article is the first real history of ipilimumab that I've seen. It's pretty dry, but it gives a good sense of how long it took the drug to go from basic research at UC Berkeley 15 years ago to a life saving treatment today.

3 comments:

  1. There are some real heroes here, making these things happen (and more advances to come). James Allison loves his work so much he named his band after the immune system:

    http://www.nytimes.com/2011/03/26/business/26drug.html

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