Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has approved the use of Merck's single-dose Emend (fosaprepitant dimeglumine) in combination with other antiemetic agents to prevent delayed nausea and vomiting in patients who receive moderately emetogenic chemotherapy (MEC).
Subscribe to our email newsletter
Emend, a substance P/neurokinin-1 receptor (NK1) antagonist, has already been approved for highly emetogenic chemotherapy.
The approval of the new indication was based on data from a randomized, double blind phase 3 study, which demonstrated that a single IV infusion of Emend in combination with ondansetron and dexamethasone offered better protection against delayed nausea and vomiting compared with ondansetron and dexamethasone alone.
A 78.9% complete response rate was observed among 502 patients assigned the Emend regimen, compared with a 68.5% complete response rate in 498 patients with the control regimen.
Merck said Emend for injection is an intravenous prodrug of the oral formulation of Emend (aprepitant). It has not been studied to treat established nausea and vomiting.
The company noted that the injection is contraindicated in patients who are hypersensitive to any part of the product. It is also contraindicated for patients who take pimozide.
Merck Research Laboratories vice president, clinical research Stuart Green said: "Despite significant advances in supportive care, nausea and vomiting has remained a challenge for many cancer patients undergoing moderately emetogenic chemotherapy – and has historically required multi-day antiemetic therapy.
"Today’s approval of an expanded indication for Emend for injection means that physicians now have a new single-dose intravenous option, combined with other anti-vomiting medicines, for the prevention of delayed nausea and vomiting in these patients."
In a separate development, Merck has signed an agreement to evaluate ImmunoGen’s mirvetuximab soravtansine in combination with its anti-PD-1 therapy, Keytruda (pembrolizumab), to treat patients with FRa-positive ovarian cancer.
ImmunoGen is carrying out a phase 1b/2 clinical trial to evaluate mirvetuximab soravtansine for FRa-positive ovarian cancer used in doublet combination with other anticancer agents.
The assessment of mirvetuximab soravtansine with Keytruda will be added to the study. The cohort is expected to open for patient enrollment in the second half of this year.
Image: Pützerturm, a landmark of the headquarters of Merck KGaA, Darmstadt, Germany. Photo: courtesy of Merck KgaA.