FDA Avastin Hearing for Metastatic Breast Cancer News - Terry Kalley Testified at Hearing

Freedom of Access to Medicines is the top resource for all the latest news on the FDA Avastin Hearing!

• We are currently livetweeting every detail of the Hearing on FAMEDS Twitter.
• Posting the great number of articles from Media Outlets and having dialogue with supporters on our Facebook Page.
• FAMEDS has the Patient Protest/Rally Videos, Photos, the Speech Terry Kalley Testified, Slideshow Presented at the Hearing and more content on our Website Hearing Page.

FDA Avastin Hearing Peaceful Protest / Rally Video

Video of FAMEDS Founder Terry Kalley Speaking at the FDA Avastin Hearing Peaceful Protest / Rally this Morning, Surrounded by Patients, Suvivors, Family, Friends, Supporters & Media:

Avastin Patient Series: Anonymous User

Below is a living example of a Metastatic Breast Cancer Patient Surviving with the Drug Avastin! Check back to read every story in this continuing series!

If you are an Avastin patient or survivor, or family member, we encourage you to share your story! You can remain anonymous as this patient chose to.  Email us with a video or written story describing your journey to Terry.Kalley@fameds.org

View Her Story:

Avastin Patient Series: Shannon's Story

Below is a living example of a Metastatic Breast Cancer Patient Surviving with the Drug Avastin! Check back to read every story in this continuing series!
If you are an Avastin Patient or Survivor, we encourage you to share your story! Email us with a video or article describing your journey to Terry.Kalley@fameds.org

Shannon's Story

via the South Charlotte Weekly in 3 Parts:

Page 1: http://fameds.org/pdf/morgan_1.pdf

Page 2: http://fameds.org/pdf/morgan_2.pdf

Page 3: http://fameds.org/pdf/morgan_3.pdf

Avastin Patient Series: Anne's Story

Below is a living example of a Metastatic Breast Cancer Patient Surviving with the Drug Avastin! Check back to read every story in this continuing series!
If you are an Avastin Patient or Survivor, we encourage you to share your story! Email us with a video or article stating your journey to Terry.Kalley@fameds.org

Anne's Story

Hello. I am currently on Avastin. I appreciate your efforts to help me and thousands of other breast cancer patients. Here is my story -

I was initially diagnosed on July 21, 2006 with IDC stage 3A, grade 3, ER/PR+ HER2-. I was 36 years old. It was recommended by my oncologist and breast surgeon that I have chemo before surgery in order to gauge my response to treatment. I was scheduled for 6 rounds of dose dense TAC (taxotere/adriamycin/cytoxin) to be given once every 3 weeks. I was told this was first line and the most aggressive approach. With my breast lump palpable, we were able to get an approximate measurement at the start of each therapy session. At first, there seemed to be some shrinkage of my tumor. Then, before my 4th round, my oncologist was aghast to realize my tumor had grown. We went ahead with my 4th chemo cycle and scheduled my modified radical mastectomy immediately. The pathology came to prove the suspicion - my cancer was unresponsive to TAC.

I feared recurrence but was assured "it was all in the bucket" and all I needed was to have the recommended radiation and take Tamoxifen. They told me since I was ER+, the hormonal medication was even more important than the chemo anyway. I agreed and began to recover. About a year after I finished "active" treatment, I was having shortness of breath with tremendous pain. I went to the local ER and was given a CT scan to check for embolism (I had a clot after my reconstruction a few months earlier). None was found. What they did find was a 5.6 cm tumor in my mediastinum and multiple smaller masses. Tamoxifen had failed to protect me. I had radiation to the tumors and followed up with what was supposed to be 6 cycles of abraxane/carboplatin/avastin – 3 weeks on/1 week off beginning in July. On September 19, 2008, I was found with No Evidence of Disease. The tumors were gone! I had completed 4 cycles in November when my oncologist suggested I stop to give my body a rest (the carbo was really tough). For maintenance, I would have my ovaries removed and go on another type of hormonal drug, Femara. Seven months later, a small lesion was found on my liver. A follow up MRI showed it to be a benign hemangioma… this diagnosis was proven false in December, 2009. A new CT scan showed the mass had enlarged to 2x4cm and there was another smaller one. Both were cancer. My oncologist immediately changed my hormonal to Aromasin while we weighed my options. It was decided I would go for a liver resection then follow up with chemo. I was told this would be my best chance at survival. After finding a willing surgeon, a consult, and pre-op procedures, it was 6 weeks before I went for the surgery. When I woke up, I thanked the surgeon… he said "don't thank me yet, your liver is covered with cancer. There are uncountable lesions on all quadrants of your liver as well as multiple sites around it. Your cancer is inoperable. " It would need 4 weeks to heal before I could begin any sort of chemotherapy.

In this time, my husband and I prayed for a miracle. In March, 2010, we changed oncologists where I had updated scans – including a brain MRI which showed 4 small lesions. Also, the situation in my liver was dire. It wouldn't be long before my liver began to fail. I was given SRS radiation to my brain lesions and then began xeloda/gemzar with avastin. After 2 cycles, my PET scan showed No Evidence of active Disease. TWO CYCLES! We had received a miracle! I completed 6 rounds doing 2 weeks on/1 week off and finished in August NED. I have remained on Avastin (with faslosex) for maintenance. My most recent scans in earlier this month continue to show No Evidence of Disease. I shudder to think what may become of me if Avastin is taken away.

FAMEDS Featured on Detroit's ABC Affiliate WXYZ Channel 7 News

FAMEDS Founder Terry Kalley is Interviewed about his fight against the FDA in order to continue Avastin use for Metastatic Breast Cancer Patients, including his wife.

FDA Employees, Pharma and Bio Employees, Medical Advocacy Groups, Patients with Serious Illnesses, Other with interest in the Medical Community

Please comment and share your thoughts on the issue of the US FDA taking the Metastatic Breast Cancer Drug Avastin off label.

Is it the right decision or could it be handled differently?

How will this affect drug development in the U.S.?

Do you fear that this will slow development of other drugs for other serious illnesses?

What does this mean for our economic competitiveness in pharma and bio?

Is the FDA too harsh in its dealings with drug companies or does it need to crack down further on dangerous drugs reaching market?