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news.The US Food and Drug Administration (FDA) has extended the priority review period by up to three months for Novartis' new drug application (NDA) of LBH589 (panobinostat), a potent pan-deacetylase (pan-DAC) inhibitor, in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.
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In March 2014, the company had submitted NDA for LBH589 to the FDA, and in May the agency granted priority review status to the compound, reducing the standard 12-month review period to eight months.
The company said that the extension to the LBH589 NDA review period follows an FDA Oncologic Drugs Advisory Committee (ODAC) meeting.
Novartis Oncology global head of Oncology Development and Medical Affairs Alessandro Riva said: "We are committed to working with the FDA as they continue to review the LBH589 NDA.
"Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options."
If approved, LBH589 will be a first-in-class treatment for patients with relapsed or relapsed and refractory multiple myeloma.
Multiple myeloma is a cancer of the plasma cells and is caused by the production and growth of abnormal cells within the plasma, which multiply and build up in the bone marrow, pushing out healthy cells and preventing them from functioning normally.
Image: After approval, Novartis’ LBH589 will be a first-in-class treatment for patients with relapsed or relapsed and refractory multiple myeloma. Photo: courtesy of Andrew.