US regulators have given MSD’s Keytruda its first regulatory approval for a gynaecological cancer.
The immunotherapy has been cleared for previously treated patients with recurrent or metastatic cervical cancer whose tumors express PD-L1.
The decision makes Keytruda the first anti-PD-1 therapy cleared for patients with advanced cervical cancer and progression on or after chemotherapy.
“Keytruda is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.
“This approval also marks the first indication for Keytruda in a gynecologic cancer and reflects our ongoing commitment to bring forward innovative treatment options across a broad range of cancers, including cancers that disproportionately affect women.”
"Even with the many advances observed across gynecologic cancers, new treatment options have been lacking for previously treated patients with advanced cervical cancer,” added Dr Bradley Monk, oncologist with Arizona Oncology, medical director of US Oncology Research Gynecology Program and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine.
“The approval of Keytruda in this indication is important news – and as an oncologist, it is exciting to see a much needed option made available to these patients.”
The indication is approved under the FDA’s accelerated approval pathway based on tumor response rate and durability of response, and so conversion to full approval may depend upon verification of clinical benefit in confirmatory trials.
The KEYNOTE-158 trial showed an objective response rate of 14.3 percent for the 77 patients whose tumors expressed PD-L1, a complete response rate of 2.6 percent and partial response rate of 11.7 percent