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Europe backs two blood cancer treatments

Approvals for J&J’s Velcade and Celgene’s Imnovid for treatment of multiple myeloma

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The European Commission (EC) delivered two lots of good news for blood cancer patients in Europe this week with approvals for Johnson & Johnson's (J&J) Velcade and Celgene's Imnovid (pomalidomide) for the treatment of multiple myeloma.

Velcade (bortezomib) was already approved in a limited number of multiple myeloma patients, but the new guidance extends its indication to cover earlier use in the cancer, which is thought to affect about 60,000 people in Europe.

Previously Velcade was available for multiple myeloma patients in Europe when used in combination with melphalan and prednisone and only if patients were ineligible for stem cell transplant, or in advance multiple myeloma patients who had failed at least one other treatment.

The updated guidance now says that Velcade can now be used in combination with dexamethasone or thalidomide and dexamethasone as a first treatment option for adults with previously-untreated multiple myeloma, regardless of their eligibility for stem cell transplant.

“This decision could mean significantly improved outcomes for many patients with this disease,” said J&J.

The approval follows the EC's decision last year to back a subcutaneous version of Velcade, with J&J looking to make the most of the drug's potential ahead of patent expiry.

This has been under treat in the US, where Velcade is marketed by Takeda subsidiary Millennium Pharmaceuticals, as Actavis is seeking to overturn sets of patents that are due to expire in 2017 and 2022.

Pomalidomide Celgene also wins multiple myeloma backing
Elsewhere in Europe, the EC granted approval to Celgene to market Imnovid, formerly known as Pomalidomide Celgene, in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma.

The approval is limited, however, and covers the use of Imnovid in adult patients who have received at least two prior therapies including both Celgene's own Revlimid (lenalidomide) and J&J's Velcade and have demonstrated disease progression.

With both Revlimid and Imnovid, Celgene now offers treatment across all stages of multiple myeloma, which leads to relapses in most patients.

The approval is based on guidance from the European Medicines Agency (EMA), which recommended that, due to risk to pregnant women, Imnovid be provided with a programme to inform doctors and pharmacists about special measures to reduce the dangers of the drug, including a requirement for all women of child-bearing potential treated with Imnovid to undergo pregnancy tests and to use selected contraception.

The drug is already available in the US under the name Pomalyst, where it was approved shortly after rival late-stage multiple myeloma treatment Onyx Pharmaceuticals' Kyprolis (carfilzomib).

Pomalyst is available as an oral treatment, however, giving it some advantage ahead of Kyprolis injection. Kyprolis is currently under review as an orphan drug in Europe.

Eric Low, chief executive of the charity Myeloma UK, described the Imnovid approval as “fantastic news”.

He said: “It means that there is now a treatment option available for patients in the relapsed and refractory setting, previously a major area of unmet need.”

“Myeloma UK will be doing everything we can and collaborating with all stakeholders to ensure that the myeloma community in the UK is able to benefit swiftly from today's decision.”


Article by
Thomas Meek

9th August 2013

From: Sales



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