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Celgene gains French reimbursement for Revlimid in multiple myeloma

HAS decides it offers ' significant improvement' over existing treatments


Patients in France will soon be able to access Celgene’s Revlimid (lenalidomide) for two cancer indications following a decision to reimburse the drug by the French National Authority for Health’s (HAS) Transparency Commission.

It’s been approved in combination with dexamethasone as a first-line treatment for multiple myeloma in patients who are not eligible for autologous stem cell transplant.

HAS’ Transparency Commission granted the combination an Assessment of Improvement of Medical Benefit (ASMR) III status. This denotes ‘significant improvement’ over existing products in the therapy area and has been awarded to less than 2% of drugs evaluated since 2015.

Tuomo Patsi, president worldwide markets, haematology and oncology, Celgene, said: “The reimbursement of Revlimid in France for newly diagnosed patients who are not eligible for transplant is very good news.

“We are continually enriching our portfolio in multiple myeloma and other pathologies that are currently incurable, with the hope that patients will be cured of their illness one day.”

According to Celgene, over one third of patients (38%) do not reach the second line of treatment or are not eligible to receive another treatment because their general condition does not allow it.

“The challenge of initial treatment for newly diagnosed patients who are not eligible for transplant is to delay disease progression and to maintain patients in the best overall state for as long as possible,” said Celgene in a press release.

Professor Thierry Facon, head of department of blood diseases, Claude Huriez Hospital, said: “Having this treatment option now available for newly diagnosed patients who are not eligible for transplant is a real step forward.

“Treating patients continuously until disease progression has an important impact on how we manage the disease over the long term.”

However, HAS handed Revlimid ASMR V status, equating to ‘no improvement’ over existing treatments, when it came to its monotherapy use in adults with relapsed of refractory mantle cell lymphoma (MCL).

Celgene said Revlimid would still offer an “additional therapeutic option” in for patients with relapsed or refractory MCL who are ineligible for intensive chemotherapy and/or transplant. But in patients with a high tumour burden, HAS’ Transparency Commission recommended Revlimid only be used in the absence of available therapeutic alternatives and under close monitoring.

Revlimid was approved by the European Commission in 2015 in combination with dexamethasone for adults with previously untreated multiple myeloma who are not eligible for a transplant. Its European licence in MCL came the following year.

Article by
Gemma Jones

6th November 2017

From: Regulatory



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