Last Wednesday (11/6/2013), Reuters reported that the approval of a new cancer drug by Curis Inc. has stalled after a patient died while taking the drug.
Curis Inc. is a company that develops many new drugs used for in cancer treatment. In collaboration with other major drug companies, Curis created Erivedge, the only medication for the treatment of basal cell carcinoma that has been approved by the FDA.
Recently, Curis has had some trouble with one of its newest cancer drugs after a death of a patient using the drug in a trial setting. The patient passed away due to liver failure, and this most recent set back has stopped the company from enrolling any new patients in the trial. The cancer drug is in an early stage trial and the risks involved are clearly not well known. The deceased patient had advanced breast cancer and died about one month after the treatment had stopped.
After screening for candidates that were appropriate for the trial, the company selected patients with advanced solid tumors or lymphomas. Lymphoma is one type of blood cancer. The body’s immune system is there to protect the person from infection and disease, however there are times when some protective agents of the immune system called B or T Lymphocytes are deformed in some way. This deformation may cause the Lymphocytes to divide faster than normal or live longer than they were meant to live. Apoptosis, or programmed cell death, is a key part in keeping the working, functioning cells healthy and able to do their job. When the body loses the ability to kill and recycle old and malfunctioning Lymphocytes, cancer (lymphoma) is a likely outcome.
The FDA is looking deeply into this most recent death and has many questions for Curis Inc. Curis said it will work together with the FDA and answer all of their questions in an attempt to make sure this type of thing does not happen again in the future. Financially, the company’s shares have fallen by 10 percent in the premarket trading and their shares have dropped to as low as 3.89 dollars.