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Medicines licensing

FDA fast tracks approval of panobinostat for multiple myeloma

The FDA has granted approval for panobinostat in combination with bortezomib and dexamethasone to treat patients with multiple myeloma.

The US Food and Drug Administration (FDA) has fast-tracked the approval of the first histone deacetylases (HDACs) inhibitor to be made available in the United States to treat patients with multiple myeloma (pictured)

Source: BSIP SA / Alamy

Multiple myeloma is a form of blood cancer that causes plasma cells to rapidly multiply and crowd out healthy blood cells from the bone marrow

The US Food and Drug Administration (FDA) has fast-tracked the approval of the first histone deacetylase (HDAC) inhibitor to treat patients with multiple myeloma.

Panobinostat (Farydak; Novartis) will be targeted at those patients with incurable blood cancer who have already received at least two standard therapies, including bortezomib and an immunomodulatory agent. It must be offered in combination with bortezomib and the anti-inflammatory dexamethasone.

Multiple myeloma is a form of blood cancer that causes plasma cells to rapidly multiply and crowd out healthy blood cells from the bone marrow. When the bone marrow becomes overloaded with plasma cells they can move to other parts of the body, weakening the immune system and causing other bone and kidney problems.

Panobinostat works by inhibiting the activity of HDACs, which can slow the development of, or kill, the plasma cells in these patients.

In clinical trials, participants given combination therapy, including panobinostat, saw an improvement in their progression-free survival of around 10.6 months compared with 5.8 months in participants who were only given bortezomib and dexamethasone. Some 59% of patients treated with panobinostat saw their tumour shrink compared with 41% of patients in the other group.

Approval of panobinostat comes four months after the FDA rejected the product for the treatment of relapsed multiple myeloma on the grounds that its risks outweighed its benefits.

Novartis submitted fresh evidence supporting its use for patients with multiple myeloma who had been treated previously with at least two standard therapies, including bortezomib and an immunomodulatory agent. It is this indication that has been approved.

“Farydak has a new mechanism of action that distinguishes it from prior drugs approved to treat multiple myeloma,” says Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Farydak’s approval is particularly important because it has been shown to slow the progression of multiple myeloma.”

Novartis intends to launch Farydak in the United States within the next few weeks, and is seeking marketing authorisation in several other countries.

“Regulatory filings are currently under way for LBH589 (panobinostat) in many countries,” a company spokesperson says. “The filing in the European Union was submitted in May 2014. The filing in Japan, given orphan drug status, was submitted in September 2014.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067986

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