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Roche gets EU approval for fixed-dose Herceptin/Perjeta combination

Treatment can be administered as an injection instead of an intravenous infusion

The European Commission has approved a fixed dose combination of Roche’s antibody blockbusters Herceptin and Perjeta under the new brand name Phesgo.

The new combination treatment, containing Herceptin  (trastuzumab) and Perjeta (pertuzumab) with hyaluronidase, has been authorised for use for the treatment of early and metastatic HER2-positive breast cancer.

The subcutaneous formulation of the two HER2-targeting drugs was equally as effective as giving Herceptin and Perjeta by intravenous (IV) infusion – the current route of administration – at achieving therapeutic levels in the blood when given alongside chemotherapy.

This means that the combination treatment can be administered as a single injection in eight minutes, with follow-up doses taking just five minutes – a much shorter duration than the previous administration, which requires a 150-minute infusion to provide a loading dose, followed by 60- to 150-minute maintenance doses.

“This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, chief medical officer and head of global product development.

“The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimise the impact of treatment on their everyday lives. It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions,” he added.

Herceptin has been hit by biosimilar competition, with much of the market share taken from Roche’s drug treatment by generic rivals from Amgen, Mylan, Pfizer, Teva and Merck & Co.

In Roche’s half-year report for 2020, sales of Herceptin had dropped by 28%, reflecting the introduction of biosimilar competition in the US and EU.

Perjeta, on the other hand, remains under patent until 2023 in Europe and 2024 in the US, growing 17% in the first half of 2020 – driven mostly by increases in China in the early and metastatic breast cancer settings.

The new, less frequent, fixed-dose combination, which is already approved in the US, could help to ward off competition from potential regimens, including IV formulations of Perjeta alongside a Herceptin biosimilar.

Article by
Lucy Parsons

23rd December 2020

From: Regulatory

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