Who: High school sweethearts Keith & Mikaela Knapp got married after graduating from college in 2011. 2 years later, Mikaela was diagnosed with Stage IV kidney cancer.
What: Since Mikaela’s diagnosis in October 2013, she has exhausted every FDA-approved treatment option available for her type of cancer. Now, with the cancer unchallenged and therefore spreading every day, the couple has been urgently seeking clinical trial options in the hopes of protecting their future together. Frustrated after numerous rejections from clinical trials, Keith put a petition up on change.org asking for support to get Bristol-Myers Squibb, Merck, or Genentech to allow compassionate use of their respective anti-PD-1/L1 immunotherapies: novalumab, lambrolizumab, and MPDL3280A.* With help from friends on a social media push, the petition was a hit – reaching almost 50,000 signatures within the first week.
*For information on anti-PD-1 immunotherapy — the breakthrough treatment that Mikaela is seeking — see this New York Times article.
Why: The goal for the petition is simple: start treating Mikaela with anti-PD-1 immunotherapy from either Bristol-Myers Squibb, Merck, or Genentech before time runs out.
How: There are 2 ways for Mikaela to receive the treatment she needs: clinical trials and compassionate use.
The couple have been pursuing clinical trials for over a month, to no avail. They continue to do so, but the continued rejections due to Mikaela’s rare cancer subtype, brain metastases, history of pneumonia, and need for systemic steroid therapy prompted the couple to pursue the compassionate use route as well.
Under the FDA’s laws, compassionate use is for patients with life-threatening illnesses who cannot access the breakthrough treatments they need via clinical trials. This process requires that the patient have an oncologist willing to oversee the treatment and a pharmaceutical company willing to provide the drug. Keith & Mikaela have already identified a local oncologist who is willing to oversee the course of treatment; also, Keith is working with a non-profit experienced in navigating the FDA approval process, and they tell him that he can expect FDA approval within a week of submitting an application. The only thing they need to submit that application is for either BMS, Merck, or Genentech to agree to provide the drug.
Petition (hosted at change.org)
News 10 Sacramento (3/21/14)
CBS 13 Sacramento (3/24/14)
ABC 11 Raleigh-Durham (3/25/14)
Daily Mail (3/27/14)
Good Morning America (3/27/14)
Oxbridge Biotech Roundtable (3/31/14)
Peter Schiff Show (3/31/14)
ABC News WRIC Richmond (4/2/14)
Brian Oxman Show (4/2/14)
National Review (4/3/14)
Al Jazeera’s The Stream (4/7/14)
News 10 Sacramento (4/7/14)