Drug for common cancer treatment side-effects gets EU approval

Drug for common cancer treatment side-effects gets EU approval

3 Jun 2015

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common side effects of chemotherapy. Despite the existence of effective treatments and clear antiemetic guidelines, many patients still suffer from CINV, particularly during the delayed phase after chemotherapy.

On 27th May 2015, the European Commission approved Akynzeo® (netupitant-palonosetron), marketed by Helsinn, for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in the European Union.

The decision followed the Positive Opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on March 26 2015 and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.

Approval based on simplification of the therapy

Akynzeo® is a new oral fixed dose combination of a highly-selective NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Akynzeo® provides a combination of two antiemetics in a single oral capsule. A scheme of an NK1 receptor antagonist, a 5-HT3 receptor antagonist and dexamethasone meets the guidelines' recommendation for optimal antiemetic therapy following highly emetogenic and anthracycline cyclophosphamide based chemotherapy.

As stated in the CHMP Summary of opinion1, the "simplification of therapy by decreasing the number of individual dose units to be taken by the patient may furthermore improve patient compliance."

“Leading to more treatment options for the patient”

Akynzeo® was already approved by the US Food and Drug Administration (FDA) and by the Australian Therapeutic Goods Administration (TGA).

Riccardo Braglia, Helsinn Group Chief Executive Officer commented: "Akynzeo® will play a significant role in preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment, which could lead to more treatment options for the patient."

Source: Medical News Today