NorthWest Biotherapeutics Inc (NWBO)

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https://www.cancer.gov/about-cancer/treatment/drugs/off-label

The Role of Off-Label Drug Use in Cancer Treatment
Research has shown that off-label use of drugs is very common in cancer treatment. Often, usual care for a specific type or stage of cancer includes the off-label use of one or more drugs.

Off-label drug use is common in cancer treatment because:

Many cancer drugs are effective against more than one type of cancer.
Cancer treatment often involves the use of combination chemotherapy.

Combination chemotherapy (which is treatment using more than one drug) is effective in treating many types of cancer. Examples of combination chemotherapy include:

R-CVP to treat non-Hodgkin lymphoma
CMF and TAC to treat breast cancer
BEACOPP to treat Hodgkin lymphoma
FOLFOX to treat colon cancer
These combinations might include one or more drugs not approved for the type of cancer they are being used to treat.

The FDA usually does not approve combinations of chemotherapy. There are so many of them that it would not be practical to approve each combination.

Research studies find new uses for drugs that are already approved. The results of research studies are published in medical journals and shared in the medical community. Doctors then adopt the new use and it may become an accepted and widely-used treatment for a different cancer, even if the FDA has not approved the drug for that use.

Health Insurance Coverage of Off-Label Drugs in Cancer Treatment
Medicare and many insurance companies pay for off-label drugs for cancer treatment, as long as the off-label uses are listed in an approved compendium. A compendium is a collection of drug summaries put together by experts who have reviewed data about the drug’s use in patients.

If your doctor prescribes an off-label drug for your treatment, check your plan to make sure the drug is covered. If coverage is denied, it may be helpful for the doctor to provide the insurance company with copies of documents that support the suggested off-label use.

The Flaskworks acquisition will definitely be needed to handle the deluge of demand for the DCVax platform. Good to know the inventors of MicroDEN are now NWBO employees and NWBO now owns the technology and all related patents.

I can imagine once DCVax-L is approved for glioblastoma, there will be patients, family/friends/colleagues of patients DEMANDING they have access off-label for other cancers, especially if there are testimonials from other cancer patients that have used DCVax successfully with the same disease.