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Home Industry News Novartis receives CHMP recommendation for multiple myeloma drug

Novartis receives CHMP recommendation for multiple myeloma drug

30th June 2015

Novartis has announced that its new drug Farydak has been recommended for EU approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The committee has adopted a positive opinion for Farydak to be used in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed and/or refractory multiple myeloma.

It is the first histone deacetylase inhibitor therapy to show efficacy in multiple myeloma, with its epigenetic activity potentially helping to restore cell function. If approved, it would be the first treatment in its class to be made available for this condition.

In clinical trials, the new therapy was associated with progression-free survival improvements of 7.8 months, when used among patients who had received at least two prior regimens, including bortezomib and an immunomodulatory agent.

Dr Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said: "We are pleased with the positive CHMP opinion on panobinostat for previously treated patients, because it brings us one step closer to providing a new treatment option for patients in need in Europe."

The company also announced the publication of new clinical trial data this week showing the efficacy of its drug secukinumab over one year in psoriatic arthritis patients.ADNFCR-8000103-ID-801792775-ADNFCR

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