- The medicine was FDA approved in combination with Inlyta, by Pfizer Inc. to treat advanced renal-cell carcinoma.
- The FDA approval was based upon results of Keynote-426 study, where a combination of Keytruda & Axitinib lowered risk of death by nearly 47% compared to Sunitinib.
Merck & Co. (Merck), a renowned American pharmaceutical company, has reportedly obtained FDA approval for its new kidney cancer therapy drug, KEYTRUDA® (pembrolizumab), designed to treat individuals with advanced renal-cell carcinoma (RCC).
Reports cite, the medicine was FDA approved in combination with Inlyta (axitinib), by Pfizer Inc. as an advanced renal-cell carcinoma therapy. The FDA approval was based upon results of Keynote-426 study, where a combination of Keytruda & Axitinib lowered risk of death by approximately 47% compared to Sunitinib.
According to a report by Reuters, theapproval, which was awarded two-months ahead of the expected dates, allows thenewly developed combination therapy to make an early market launch, ahead ofits rival products.
The Vice President of Clinical Research at Merck Research Laboratories, Dr. Scot Ebbinghaus stated that the approval represents a newly-developed treatment option for patients suffering from advanced renal-cell carcinoma. The patients would now have access to KEYTRUDA as under a first-line combination regimen. Dr. Ebbinghaus stated that the FDA’s approval reflects Merck’s commitment to its patients with cancer & also further supports the use of the drug to help enhance survival outcomes for individuals suffering from renal-cell carcinoma.
The Cleveland Clinic Cancer Center Medical Oncologist & Prof. of Medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Dr. Brian Rini stated that given the aggressiveness of the disease, many patients suffering from advanced renal-cell carcinoma require additional treatment options which could help enhance survival outcomes. Dr. Rini further added that a combination of Pembrolizumab & axitinib provide an important therapeutic option for doctors to consider when deciding on initial treatments for newly diagnosed patients.
According to reports, the exact date of the drug’s early market launch has not been unveiled yet.