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FDA Approves Merck’s Keytruda Treatment for Endometrial Carcinoma
Other FDA approvals include AstraZeneca’s type 2 diabetes treatment, a rare genetic disorder treatment, and AbbVie’s treatment for acute bacterial skin and skin structure infections.
FDA recently approved the combination of Merck’s monoclonal antibody, Keytruda, and Eisai’s tyrosine kinase inhibitor, Lenvima, for the treatment of patients with advanced endometrial carcinoma.
The combination treatment is intended for patients who experienced disease progression following systemic therapy, who have endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and who are not candidates for curative surgery.
FDA based its approval on Merck’s Phase 3 KEYNOTE study. The trial enrolled 827 patients with advanced endometrial carcinoma who had been previously treated with at least one prior platinum-based chemotherapy regimen in any setting.
In the study, Keytruda plus Lenvima showed statistically significant improvements in overall survival, reducing risk of death by 32 percent and risk of disease progression or death by 40 percent versus chemotherapy.
The combination treatment also elicited an objective response rate of 30 percent versus 15 percent for patients who received the investigator’s choice of doxorubicin or paclitaxel.
“The FDA approval of KEYTRUDA plus LENVIMA for the treatment of patients with certain types of advanced endometrial cancer is an important step forward towards helping this patient community that has had limited treatment options,” Takashi Owa, MD, chief medicine creation officer and chief discovery officer of oncology business group at Eisai, said in the announcement.
“We owe our deepest gratitude to those who participated in our KEYNOTE-775/Study 309 trial, their families and clinicians, and to our employees, whose collective commitment made this meaningful milestone possible,” Owa continued.
Women with endometrial cancer who are not candidates for curative therapy and have disease progression following prior systemic therapy have a five-year survival rate of 17 percent.
The FDA approval helps patients fight this malignancy and allows physicians to provide a treatment option that may improve survival outcomes, according to Vicky Makker, principal investigator and medical oncologist at Memorial Sloan Kettering Cancer Center.
FDA Approves AstraZeneca’s Type 2 Diabetes Treatment
FDA recently approved AstraZeneca’s Bydureon BCise, a once-weekly injectable suspension for the treatment of type 2 diabetes.
Bydureon BCise improves glycemic control in pediatric patients 10 to 17 years of age as an adjunct to diet and exercise. FDA’s approval is the first regulatory approval for a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) in this population.
The agency based its approval on positive results of the BCB114 Phase 3 trial in children with type 2 diabetes. The trial showed that Bydureon BCise, on top of standard care, significantly improved glycemic control compared to placebo in pediatrics.
“This decision is an important milestone for the care of this younger patient population by providing a convenient, once-weekly treatment option,” Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca, said in the announcement.
“The Phase III data that supported this approval demonstrated the safety and tolerability of exenatide extended-release in younger patients was similar to the proven safety profile of this medicine in adults,” Pangalos continued.
The global rate of children with type 2 diabetes has increased since the mid-1990s, particularly in the US, as the percentage of children who are overweight or obese has risen.
William Tamborlane, MD, department of pediatrics at Yale School of Medicine, said that the FDA approval is an important milestone for the treatment of children with type 2 diabetes and brings an important new therapeutic option to physicians caring for children with the disease.
FDA Approves Albireo Pharma’s Bylvay for Rare Genetic Disorder
FDA recently approved Albireo Pharmaceuticals Bylvay for pruritus in progressive familial intrahepatic cholestasis (PFIC), a rare genetic disorder that causes progressive liver disease.
Bylvay is a non-systemic ileal bile acid transport inhibitor (IBATi) that does not require refrigeration and is easily administered as a once-daily capsule or sprinkled onto soft foods. It is the first drug approved for pruritus in all subtypes of PFIC.
Albireo Pharmaceuticals is launching Bylvay immediately to boost access to care for both patients and families impacted by PFIC.
“Treating children with PFIC can be difficult and frustrating given the current treatment options. Bylvay gives us a non-surgical option and will change how we treat PFIC,” Richard Thompson, professor of molecular hepatology at King’s College London and principal investigator of PEDFIC 1 and PEDFIC 2, said in the announcement.
“With this approval, my colleagues and I now have the opportunity to revisit how PFIC patients are being managed and we are hopeful for better outcomes for these children,” Thompson continued.
FDA based its approval of Bylvay on data from the largest global Phase 3 trials ever conducted in PFIC, PEDFIC 1 and PEDFIC 2.
In PEDFIC 1, Bylvay met both its pruritus and serum bile acid primary endpoints and was generally well tolerated. In the PEDFIC 2 extension study, Bylvay maintained reductions in serum bile acids and showed improvements in pruritus assessments, growth, and other markers of liver function in patients treated up to 48 weeks, researchers said.
FDA Approves AbbVie’s Dalvance for Acute Bacterial Skin Infections
FDA recently approved AbbVie’s Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.
Dalvance is the first single-dose option administered as an infusion to treat ABSSSI caused by designated susceptible Gram-positive bacteria in pediatric patients, including infections caused by methicillin-resistant Staphylococcus aureus.
FDA based its approval on a multicenter, open-label clinical trial evaluating Dalvance in 183 pediatric patients from 10 to 17 years of age with ABSSSI.
Patients were randomized to receive single-dose Dalvance, 2-dose Dalvance, or comparator. The primary objective of the study was the evaluate the safety and tolerability of the drug.
Overall, researchers discovered that the proportion of patients with an early clinical response was 97.3 percent in the Dalvance single-dose arm, 93.6 percent in the Dalvance 2-dose arm, and 86.7 percent in the comparator arm.
“Serious infections in children can be difficult to treat and the impact of ABSSSI among children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” Margaret Burroughs, medical director of infectious diseases at AbbVie, said in the announcement.
“This pediatric approval for DALVANCE as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI,” Burroughs continued.
