I have written several articles about the chemotherapy drug, Avastin, this year: Avastin Proving To Be Versatile–Although Sometimes Controversial Chemotherapy Drug, and this article from the ASCO meetings in June – Avastin Extends Progression-Free Survival By 39% In Women With Previously Untreated Ovarian Cancer.
But later this summer, things started to unravel, with the FDA yanking approval for Avastin’s use in breast cancer patients.
One of our readers, Nick from California, forwarded me this CNN Health article about Avastin yesterday:
Looming ruling on breast cancer drug splits patient advocates
By Caleb Hellerman, CNN
September 15, 2010
(CNN) — Marcia Gilbert has spent most of her life in Charlotte, North Carolina, but for the end of summer, she decided to make a special trip.
Gilbert, 56, spent the weekend before Labor Day in New York City. She roamed from Chinatown to the Upper East Side, went sightseeing in Central Park and painted the town with her husband of 33 years, their two 20-something children and assorted friends.
One evening, they found themselves at Del Posto, a chic Italian restaurant. Glancing at her watch, over the sparkle of conversation, wine glasses and half-eaten dessert, Gilbert marveled at the time: just a few minutes to midnight.
“It was awfully late for me,” she laughed as she told the story. “It was just a great moment to know that I was holding up enough to be there, to feel great and make memories.”
Late-night hours, any hours, are especially precious to Gilbert, who could have been forgiven for feeling just a bit weary. For 15 years, she’s been fighting breast cancer.
After years of ups and downs, Gilbert is doing well and gives most of the credit to her most recent medicine: bevacizumab, better known by its brand name, Avastin. But gratitude is tinged with worry, because the Food and Drug Administration is considering the unusual step of revoking its approval of Avastin as a treatment for metastatic breast cancer.
“It’s disheartening, and it’s a scary thought,” says Gilbert. “Until just recently, I didn’t know it was so precarious.”
Avastin, which works by cutting off a tumor’s blood supply, was first approved as a cancer treatment in 2004 as a therapy for colon cancer. Since then, it has also been approved as a treatment for certain types of lung, kidney and brain cancer.
In 2008, the FDA granted Avastin what’s known as accelerated approval as a therapy for metastatic breast cancer. The move was based on preliminary studies that found the drug increased the time that patients went without symptoms getting worse. As a condition of the approval, the company that makes Avastin — Genentech — agreed to conduct more extensive research.
The results of those two larger trials, known as RIBBON-1 and AVADO, were made public this year, and to some, they were disappointing. In RIBBON-1, time without symptoms getting worse, known as progression-free survival, or PFS, improved by less than three months.
This is only the first half of this very interesting story. Go to Avastin Trial Results Disappointing to read more.
I listened to a balanced report about this issue on public radio last week. Several patients were interviewed. One felt Avastin had saved her life. But oncologists on the show were critical and worried about overall patient safety. But despite her concerns, one of the oncologists felt removing Avastin from her “arsenal” of breast cancer drugs would make it harder to treat certain patients.
Maybe the drug can be improved or better targeted for use against breast cancer?
Feel good and keep smiling! Pat