A new approach to treating myeloma works at the cellular level using gene therapy that works with the body’s immune system to destroy cancers. Unlike chemotherapy that may destroy the immune system, or radiation that damages adjacent tissue, the monoclonal antibody works to inhibit a specific protein on the surface of a cancer cell. This treatment is for patients where other types of treatment have failed or the myeloma has recurred.
The article that was released by Charles Bankhead of MedPage Today on Nov. 16, 2015 is titled “FDA Approves Potential Myeloma Game Changer.” The byline is Daratumumab is first-ever monoclonal antibody therapy for multiple myeloma. This therapy targets the CD38 surface protein on a cancer cell, which also appears on several other hematologic cancers and solid tumors.
Richard Pazdur, MD of the FDA’s Center for Drug Evaluation and Research stated that this offers an opportunity to treat cancers that have been resistant to other treatments.
Targeting proteins that are found on the surface of cancer cells has led to the development of important oncology treatments. Darzalex provides another treatment option for patients with multiple myeloma who have become resistant to other therapies.
FierceBiotech is a biotech industry publication. John Carroll released an article on Nov. 16, 2015 titled “J&J nabs an early OK for ‘breakthrough’ multiple myeloma blockbuster contender Darzalex.” Johnson & Johnson paid $1.1 billion to the developer Genmab for rights to the drug. The monthly cost for this new drug is $11,212. The monthly cost for Tagrisso, another new cancer medication from AstraZenica, is $12,750. The FDA approval gives J&J an earlier entry to this market ahead of Bristol Meyers-Squibb and AbbVie.
The FierceBiotech article provides the costing and results for Darzalex.
Daratumumab is given once a week for the first two months of treatment, then the infusions wind down to once monthly in the second 6 months of the year, says a spokesperson for J&J. For the first full year–with a total of 23 doses given at a cost of $5,850 per infusion–the average monthly wholesale acquisition cost is $11,212, says J&J, or $135,550 for the first year. In year two, and any year thereafter, patients receive a total of 13 doses, for a monthly wholesale cost of $6,337, or $76,044 annually. J&J also offers programs to limit patient’s out-of-pocket costs and will be offering payers discounts during price negotiations.
Focusing on the group of patients getting the top dose, investigators reported in The New England Journal of Medicine last August that the drug scored an impressive 36% overall response rate among 42 patients with late-stage multiple myeloma–a step up from the 29% overall rate that was reported at ASCO earlier in the year. And two-thirds of the responder group benefited from progression-free survival after 12 months of therapy. The dose-escalating study also satisfied researchers that they would be able to use the 16-mg dose for all future studies of the drug, an IgG1k antibody that binds to CD38 on the surface of multiple myeloma cells.
While it is very exciting to see a drug that works against multiple myeloma when other chemotherapy drugs have failed, the yearly costs are huge. J&J and the other drug suppliers often assist patients in the costs, but these new drugs are prohibitively expensive. J&J is going to have to sell 8,176 patient years of treatment to get its return on the $1.1 billion investment, if it is sold at list price. There is no doubt that cancer prevention is a small fraction of the costs of cancer treatments.
Gene therapy may offer a true cure versus the limited life extension offered by many conventional chemotherapy and radiation approaches. We need to keep pressure on Congress and the government agencies, e.g. the FDA, CDC and EPA, to keep carcinogens out of our food, water and air. Individuals need to keep their immune systems as strong as possible through proper diet, exercise and stress management. The best cures cannot match the body that is working properly.