Helsinn commences Netupitant/Palonosetron Phase III combination study in CINV

Helsinn Group and Eisai Inc. announced today that Helsinn has commenced a multi-centered Phase III clinical study program investigating the Netupitant/Palonosetron (300mg/0.50mg) oral fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting (CINV).

The Phase III program, reviewed by the FDA and EMA, consists of three studies which are expected to enroll 2,600 oncology patients receiving highly or moderately emetogenic chemotherapy in approximately 250 study sites in 18 countries.

"The commencement of this Phase III program is an important milestone in the development of this investigational compound, our commitment of giving cancer patients additional options for the prevention of CINV and for providing supportive care therapies for patients in their fight against cancer," said Dr. Riccardo Braglia, Chief Executive Officer of Helsinn Group.

Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for the fixed-dose combination product in the United States (if approved). Under the terms of the agreement, Helsinn is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC], preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). If approved by the FDA, the fixed-dose combination product will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. company of the Swiss group.

Lonnel Coats, President and CEO of Eisai Inc., said: "We are pleased that the Phase III clinical program is underway and look forward to the possibility that, if approved, this investigational compound may one day bring benefit to patients who experience CINV."

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Study shows cannabis as a genotoxic substance with cancer risks