"Compassionate use": PPHM will soon have its hands full (Who needs a partner?!) I would prescribe or use Bavituximab today: Single patient access
Patients who don’t qualify for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access.
In this case, the patient’s doctor must first ask the drug company if the drug can be used for the patient and see if the drug company will supply it. If the company agrees, the patient’s doctor works with the drug company to ask the FDA to approve the drug for use by this one patient.
The FDA requires the doctor to send information about the patient, why the request is being made, the proposed treatment plan, and a signed informed consent from the patient (see our document Informed Consent for more information). The length of time it takes to get single patient access varies. But if it is an emergency, the FDA can complete the paperwork in 24 hours.
Why use drugs that aren’t approved?
According to guidelines from the National Cancer Institute, most compassionate drug use is for patients who meet all of these conditions:
• Have advanced disease
• Have used standard treatments and they have not worked
• Are not eligible for any clinical trial that’s in progress
• Have no other treatment options
• Have a type of cancer for which there is reason to expect the investigational drug will help
• Are likely to have benefits that outweigh the risks involved
In a case like this, the doctor may consider trying to get a new, unapproved drug for a patient to see if it will help.
Cancer surgeons understand this stuff because the wrestle gnarly tumors out of bodies all the time. Oncologists do "the standard of care" for the most part, and seldom touch cancer. Anything new to them is a potential lawsuit, lost income, threatening, or a hassle. That applies to many (NOT ALL). Radiation therapists seldom handle tumor or see patients. All the triumvirate (surgeons, oncologists, radiation therapists)understand the ramifications of Bavi treatment. A syllogism(Greeks??????sµ??syllogismos "conclusion," "inference") a kind of logical argument in which one proposition [the conclusion] is inferred from two or more others [the premises] of a specific form): If Bavituximab extends life > 2x in advanced lung ca
