New treatment For Bladder Cancer
- The FDA has approved the first new alternative to surgery for bladder cancer patients in 20 years
- The new treatment uses an immunotherapy drug called Keytruda
- 40% of patients had a complete response to the drug, and 20% still showed a complete response after one year
“The primary significance is that it’s an option other than radical surgery,” says Dr. Arjun Balar, Director of Genitourinary Medical Oncology at NYU Langone Health's Perlmutter Cancer Center. According to Dr. Balar, the principal investigator of the research that led to the new approval, “surgery (for bladder cancer) is highly curative, but its associated with substantial impact on quality of life and that impact is permanent,”Read More
The surgery that is usually used to treat non-muscle invasive bladder cancer, according to Dr. Balar, is very effective in treating the disease. But after the surgery associated with bladder cancer, patients usually live with a bag to divert urine and the risk of complications is very high. Moreover, 1 out of every 20 people who have the surgery die due to the treatment.
In the study that led to the approval, 40% of patients responded to the drug, and 20% were still responding to the drug after one year, meaning one out of five patients in the study wouldn't have to have their bladder removed.
This approval marks the first FDA approval for non-muscle invasive bladder cancer patients since 1998, when the FDA green-lighted Valrubicin, but doctors seldom use Valrubicin because it is not very effective. “[Valrubicin does] kill off a lot of the cancer cells, but they usually grow back, usually within six months,” said Dr. Balar.
“On January 8, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy,” wrote the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur in an official FDA statement.
The most common side effects of the drug, according to the FDA release, were fatigue, diarrhea, rash, itching, pain in the muscles and bones, blood in the urine, cough, joint pain, nausea, constipation, urinary tract infection, peripheral edema or swelling, hypothyroidism, and nasal inflammation, according to the statement.