Release date: 2015-07-01
The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has taken positive feedback on Novartis's Pabisstat capsules.
This positive opinion is aimed at the combination of pabisstat with bortezomib and dexamethasone for the treatment of at least two regimens including bortezomib and an immunomodulator (ImiD). Adult patients with recurrent and/or refractory multiple myeloma. If approved in the European Union, Pabis will be the first drug in these anticancer agents for these patients.
Multiple myeloma is a plasma cell carcinoma that belongs to a type of leukemia that develops in the bone marrow, affecting approximately 84,000 people in Europe. Pabisstat is the first deacetylase (HDAC) inhibitor to be shown to be effective against multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help restore cellular function in patients with multiple myeloma.
Pabisstat is the first HDAC inhibitor recommended by CHMP for patients with multiple myeloma
"Pabisstat is the first and only HDAC inhibitor recommended by CHMP for multiple myeloma patients undergoing standard treatment of bortezomib and an ImiD," Novartis Oncology Department Cancer Development and Riva, MD, Global Director of Medical Affairs, said. "We are very pleased that CHMP has given positive advice to Pabis, which is used in the treatment of previously treated patients, as it has taken us a step forward in providing a new treatment option for patients in Europe."
The CHMP recommendation is based on the validity and safety data of a subgroup of 147 patients analyzed during the Phase 3 trial. The trial found that paclitaxel increased their mean progression-free survival (PFS) benefit compared with patients treated with bortezomib and one IMiD compared with placebo.
The European Commission usually follows the CHMP recommendations and will make the final decision within three months of the CHMP recommendation. Its decision will apply to all 28 member states of the European Union plus Ireland, Norway and Liechtenstein.
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Source: europeanpharmaceuticalreview
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