According to a recent article from BusinessWire, the European Commission (EC) has approved KEYTRUDA as a monotherapy for adult patients with renal cell carcinoma (RCC). Specifically, this approval is indicated for RCC patients living at a heightened risk of recurrence after a nephrectomy, or a nephrectomy alongside the resection of metastatic lesions.
Approval for KEYTRUDA
The approval of KEYTRUDA, also referred to as pembrolizumab, is very positive for RCC patients, as it addresses an unmet need within this population. Now patients in all 27 countries of the European Union, along with Northern Ireland, Norway, Lichtenstein, and Iceland, will be able to receive KEYTRUDA.
The EC made its decision based on the Phase 3 KEYNOTE-564 trial, which was a double-blind, randomized, multicenter, and placebo-controlled study. 994 patients were enrolled in an effort to evaluate KEYTRUDA in regard to investigator-assessed disease-free survival (DFS). The secondary endpoint was overall survival (OS).
After being randomized 1:1, half of the group was treated with 200 mg of KEYTRUDA every three weeks, while the other was given a placebo. Both groups were treated for a year unless one experienced disease recurrence or unacceptable toxicity. Results include:
- 32% reduction in disease recurrence and death after 23.9 months
- This reduction grew to 37% after 29.7 months
- OS is still being evaluated
- Most adverse events (AEs) were of grade 1 or 2 severity
- The most common AEs include nausea, diarrhea, and fatigue
These results are what pushed the EC to approve of the drug, which addresses an unmet need within the RCC patient population. With this approval, doctors are better equipped to fight disease recurrence.
About RCC
RCC is a form of kidney cancer that typically begins with a single tumor in one kidney but easily spreads to the lungs and throughout the body. Symptoms often do not appear until this spread has occurred, which can impact diagnosis and intervention. They include abdominal pain, fatigue, high blood pressure, bloody or discolored urine, weight loss, fever, enlarged testicles, varicose testis vein, and vision abnormalities.
While medical professionals are unsure as to what exactly causes RCC, they do know that there are a number of risk factors. These include smoking and a history of kidney problems. Research has also linked mutations in the TFE 3, PRC, and VHL genes to this cancer. Treatment consists of removing the kidney, bladder, and any necessary surrounding tissue. Other treatment options include Proleukin, chemotherapy, sorafenib, hormone treatments, ablation, and Afinitor.
