Reuters, the international news agency out of London, has announced that the FDA has given a new drug “accelerated approval,” for the treatment of follicular lymphoma.
The drug, Aliqopa (copanlisib), showed complete or partial shrinkage of tumors in 59% of study participants during drug studies, with sustained results for more than 12 months for those cited.
What does accelerated approval mean?
The FDA’s accelerated approval status grants recognition of the initial positive results, but calls for additional trials to further substantiate those outcomes.
Aliqopa acts by preventing the formation of certain enzymes needed for cell growth, including cancer cells. Its use is reserved for people who’ve had at least two prior treatments for this type of cancer of the lymph system.
While there are a number of types of lymphoma, to include the childhood type and an AIDS-related variety, this article will concentrate on the adult-version of follicular lymphoma.
Follicular lymphoma is a type of non-Hodgkin lymphoma, a cancer of the lymph system that moves at a slow pace. More than 72,000 people are expected to be newly diagnosed with some type of non-Hodgkin lymphoma in 2017.
Lymphoma is a cancer of the lymph system. This system is a sort of tubular highway travelling within the human body as a connective conduit between certain organs such as the spleen and bone marrow, plus lymph nodes, and the bloodstream. It is part of the body’s immune system.
What does the lymph system do?
One of the functions of the lymph system is to collect lymph fluid from various parts of the body and return it to the blood stream.
Additionally, a major job of the lymph system is to fight off infection and disease. At various “stopping points” along its route, such as in the neck, underarms, belly, pelvis and groin, small nodules filter the lymph fluid to capture and store the white blood cells for use in fighting infection. These nodules are referred to as lymph nodes.
Another major component of the human immune system is a type of white blood cell referred to as lymphocytes. There are two predominant types of lymphocytes: One kind are known as B- cells and the other as T-cells.
Newly found cells
Recent research findings have also identified a third type of white blood cell engaged in this process. They are called natural killer cells (NK cells) that attack cancer cells and other viruses.
Lymphocytic B-cells produce antibodies that attach to bacteria or viruses that enter our body. As cancer cells are viral material, this is a major factor in the body’s response to the cellular attack. This joining process makes the cells identifiable by the immune system as cells needing to be destroyed.
On the other hand, Lymphocytic T-cells are not only crucial in speeding up or slowing down the action of other immune system functions, but are also involved in the process of cell destruction. Additionally, they assist the B-cells in producing antibodies.
Before we dig deeper into the disease of follicular lymphoma, we need to know a bit about the two types of lymphoma; their differences dictate prognosis and the type of treatment intervention.
Hodgkin vs. non-Hodgkin
There is both Hodgkin’s lymphoma (Hodgkin’s Disease) and non-Hodgkin lymphoma. While each show up in the white blood cells, with Hodgkin’s disease, there is also the presence of abnormal cells referred to as Reed-Sternberg cells. When seen under the microscope, their presence is the definitive marker for Hodgkin’s Disease.
Of the two, Hodgkin’s Disease carries the best prognosis. It is one of the most curable types of cancer, and allows for the best survival rates when diagnosed in persons under age 45.
Follicular lymphoma, on the other hand, is a type of non-Hodgkin lymphoma (NHL). But, in contrast to some other types of NHL that are aggressive, spread quickly, and need immediate treatment, follicular lymphoma is not aggressive and treatment can often wait over a period of time while its status is closely monitored.
The amazing thing is that follicular lymphoma may sometimes go away by itself without any treatment. Nevertheless, the person would still need to be closely watched as follicular lymphoma is known to often return and sometimes in a more aggressive form.
Because Hodgkin’s cancer begins in the lymphatic highway which connects to major body organs, this disease can eventually spread to the lymph nodes, bone marrow, spleen and to other body organs as well.
Hodgkin’s follicular lymphoma risk factors
Concerning risk factors for the development of Hodgkin’s follicular lymphoma, The American Society of Hematology informs us there may be a familial predisposition (although research has not fully proven this) and adds, “Characterization of genetic susceptibility in lymphoma is rapidly evolving” (James R. Cerhan and Susan L. Slager).
Common risk factors for developing non-Hodgkin’s lymphoma are “being older, male, and white”, according to the NIH National Cancer Institute.
The Institute also notes that a person taking anti-rejection medications following an organ transplant is also at higher risk, as are those with certain inherited immune disorders such as Wiskott-Aldrich Syndrome (a genetic disorder characterized by eczema and a reduced ability to form blood clots). And, an autoimmune disease such as rheumatoid arthritis, or being infected with HIV/AIDS or the Epstein-Barr virus makes one more susceptible as well. Finally, having a helicobacter pylori infection (a certain type of intestinal bacteria) can also make one more at risk.
According to the National Institute of Health:
- Symptoms of follicular lymphoma are somewhat generalized and may mimic the flu. Common complaints include painless swelling of lymph nodes, shortness of breath, extreme tiredness, night sweats, weight loss, and extreme tiredness.
- When a person with these symptoms first sees a doctor, the initial course of treatment may be an antibiotic to clear up a suspected lymph node infection. If that doesn’t cure the nodule swelling, and there are other symptoms suggestive of cancer, the physician would then order an out-patient biopsy of the affected node(s).
- If the biopsy is positive for follicular lymphoma, the doctor would suggest the patient have additional tests such as a CT and/or PET Scan to locate any cellular cancer activity. A Flow cytometry to examine cell type and to search for any tumor markers on the cell surface may also be ordered and, to determine if the cancer has spread, a bone marrow biopsy may also be done.
If cancer is found, other tests may be done to study the cancer cells more closely and to also determine the stage of the cancer. The staging process determines which areas of the body have been affected by the Follicular Lymphoma and would be used to determine appropriate treatment.
The stages of lymphoma are defined as follows:
- Stage I – Only one lymph node region is involved, or only one lymph structure is involved.
- Stage II – Two or more lymph node regions or lymph node structures on the same side of the diaphragm are involved.
- Stage III – Lymph node regions or structures on both sides of the diaphragm are involved.
- Stage IV – There is widespread involvement of a number of organs or tissues other than lymph node regions or structures, such as the bone marrow.
When a stage is assigned, it also includes a letter, A or B, to denote whether fever, weight loss, or night sweats are present. "A" means these symptoms are not present; "B" means they are. For example, a person with stage 1B disease has evidence of cancer in one lymph node region and has "B" symptoms (fever, weight loss, or night sweats).
Treatment options depend upon the stage of the cancer and can include radiation and chemotherapy plus IV immunotherapy with drugs which specifically target the diseased lymphocytes (Wolters Kluwer).
Or, as pre-noted, for Stage I, no treatment may be required at the time of diagnosis.
There is no doubt that patients with follicular lymphoma and the medical professionals who treat them are eagerly awaiting the outcome of the Aliqopa studies and the hopeful FDA approval to prescribe that drug for the treatment of this condition.