CR Day 148: FDA hearing; summary of my case

Today I gave testimony at a committee hearing at the Food and Drug Administration. The forum was the FDA's joint Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC) meeting. They were considering an application to approve a new drug named MCNA for non muscle invasive bladder cancer. Although I have not been treated with that particular drug, I was asked by BCAN's executive director, Monica Smith, to provide a brief statement of my journey with bladder cancer to illustrate the need for new drugs, and to remind the committee of the importance of their work. My statement followed Monica's statement, who spoke of the extent of bladder cancer and the fact that the FDA has not approved a significant new bladder cancer drug for nearly 30 years. 

For what it's worth, following is the outline that I prepared for my statement:

Name
Although I'm a patent attorney, I'm here as a BC patient. No financial relationship or compensation by any person or entity. 
Blogging re journey: search for Ken's Cancer Blog. About 350 entries, hundreds of thousand of views. No ads or compensation. BCAN volunteer. 

Diagnosed in Nov 2011 at age 49
Uro: BCG candidate if NMIBC
1st TURBT inconclusive for staging
Intense review of literature and consultations to know options
Second TURBT: MIBC, primary tumor T2b, plus 10 other tumors T1 and CIS. High grade micropappillary
Baseline CT and PET negative for mets
Concluded bladder could not be saved
Consensus: neoadjuvant GemCis chemo
CT after 3 rounds showed mets in multiple nodes

Discontinued chemo, rushed into surgery (RC with neo, prostectomy, 61 nodes)
Surgical pathology trifecta: upgrade to T3, andenocarcinoma in prostate, and 12 positive nodes
NCI SEER data show that 85% of mets BC die within 5 years.  
No established second line therapy
Enrolled in clinical trial sponsored by Dendreon but randomized into control group: watchful waiting. Ongoing neobladder issues (strictures, nocturnal incontinence, sleep deprivation). 

15 months later, distant mets found in supraclavicular node, confirmed by biopsy
Debate among treatment team re next therapy: 3 supported more chemo, 2 opposed
Commenced ddMVAC in Sept 2013. Discontinued after 3 rounds. Peripheral neuropathy. Mets stable for 9 more months. 
Distant mets resumed growth in fall 2014. While being evaluated for a clinical trial at NIH, CT scan found extensive PE. Treated with LMWH. 
By Jan of 2015, tumors were extensive, growing at >1 cm/month

Evaluated multiple immunotherapy trials, first mets BC patient in nivolumab trial at JHUH
Nivolumab (Opdivo) is an anti-PD1 drug being developed by BMS
After 6 rounds, CR, target tumors NED. 
As of 11/5, Largest non-target tumor is 7 mm on long axis. 
20th infusion tomorrow.  Protocol calls for up to 2 years of drug. 
Durability unknown.

I get lots of Q's through my blog and BCANs web site: crying need for new therapies
Not a doc. No medical advice. Encourage patients to be proactive, seek 2d opinions, look at clinical trials. 
Grateful to my health care team, researchers, pharma, NIH, and members of this committee. 
No position on MCNA. Many patients and their families rely and depend upon your work to evaluate and decide whether to approve new therapies. The need is great. 

Thank you.