Bladder cancer is the 9th most common type of cancer in the world with 430,000 new cases alone diagnosed in 2012 according to the World Cancer Research Fund International. Previously patients with bladder cancer, urothelial carcinoma, (UC) had two main options: standard platinum-containing chemotherapy, and surgery. So, for those whose tumor was unresectable (not able to be removed via surgery) and who were not responding well to chemotherapy they were pretty much out of options. Now, there may be a third option. In May, the FDA announced the accelerated approval of Imfinzi a drug for bladder cancer that is showing promising results in clinical trials. According to the CEO of AstraZeneca’s “We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer. Imfinzi is the cornerstone of our extensive Immuno-Oncology program, in development across many tumor types, as monotherapy and in combination” (Soriot). While this is exciting news the drug does come with a hefty price tag of about 15,000 USD per month for treatment.
This new drug is particularly exciting for its longevity in the body. Clinical trials showed that some patients continued responding to the drug up to six months later and a few for over twelve months. Treatment consists of a dosage of 10 mg per Kg of body weight given via infusion over a 60-minute period every two weeks until the cancer is considered to be in remission or levels that are considered to toxic in the body are reached and treatment has to be discontinued (AstraZeneca’s Imfinzi). While Infimizi has its own side effects to be dealt with it is encouraging to have more weapons in the arsenal to fight back. According to AstraZeneca’s website these adverse reactions include: pneumonitis, hepatitis, colitis, endocrinopathies (including adrenal insufficiency, hypophysitis, or Type 1 diabetes mellitus), nephritis, rash, thrombocytopenic purpura, infection, infusion-related reactions, or embryo-fetal toxicity.
The body’s own immune system is a powerful tool in fighting off various diseases including cancer. One might assume at the point that cancer has taken root in the body that the immune system has failed. While this is partially true it is not the whole story. There are several mechanisms in place in the body’s immune defenses that create a chain reaction of sorts. One of the defenses in the chain reaction could have failed thereby disabling or partially disabling the body’s defenses. What if there was a way to turn those failed defenses back on so cancer could be fought from the inside out -from the body’s own amazingly adapting cells? Infimizi and other drugs in the PD-L1 class may do just that. Infimzi belongs to a class of medicine called PD-L1 which falls under the checkpoint inhibitor category of cancer drug which is designed to encourage the body’s own immune system to fight back against just such an invader.
What FDA Early Approval Means
According to the FDA’s website early approval means “these regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint” (FDA).
Imfinizi is meeting this by acting as the second line of defense against bladder cancer when other methods have failed. While early approval is exciting the early approval can be withdrawn depending on how the drug continues to approve in trials or the label indication of the drug changed if the benefits are not seen to outweigh risks, basically meaning if the side effects are shown to be even more dangerous than the disease itself. Overall it is an encouraging step in the right direction towards fighting cancer from every angle.
Soriot, P. (2017, May 1st) AstraZeneca’s Imfinzi (durvalumab) receives US FDA accelerated approval for previously treated patients with advanced bladder cancer. Retrieved from https://www.astrazeneca.com
U.S. Food and Drug Administration (2014, September 15th) Accelerated Approval. Retrieved from https://www.fda.gov
World Cancer Research Fund International. (2014) Bladder Cancer Statistics. Retrieved from http://www.wcrf.org/