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Novartis faces FDA rejection for myeloma drug

Concerns over toxicity of panobinostat
Novartis building

Novartis' cancer pipeline took a hit after an advisory committee to the US FDA voted against the approval of its new drug in blood cancer.

The Swiss company released a statement saying that the FDA's Oncologic Drugs Advisory Committee did not recommend its compound panobinostat (LBH589) in combination with Takeda's Velcade (bortezomib) and the chemotherapy dexamethasone in people with previously treated multiple myeloma.

The 5-2 vote comes ahead of a final decision by the FDA, which does not have to follow the recommendation but will take it on board when making up its mind.

The outcome is a blow for Novartis, which is trying to cement its place as one of pharma's leading oncology companies after agreeing a deal earlier this year to acquire GlaxoSmithKline's (GSK) cancer portfolio.

In terms of potential revenues panobinostat – a potential first-in-class pan-deacetylase (pan-DAC) inhibitor - ranks behind some important products for Novartis in the area, but the company was still displeased with the panel's recommendation.

"We are disappointed by this voting outcome and believe the results from our clinical trials provide strong evidence to support LBH589 as a potential first-in-class treatment option for multiple myeloma, a cancer where an unmet patient need exists," said Bruno Strigini, president, Novartis Oncology.

According to documents released ahead of the meeting, experts on the panel were not in doubt over the benefits of panobinostat – the drug has demonstrated it is able to improve progression-free survival (PFS) – but there were concerns over its safety record.

Data from a phase III trial showed that 7% of patients in the panobinostat arm died from non-cancer complications compared to just 3.5% in non-panobinostat group. Reported symptoms included myelosuppression, haemorrhage, infection, gastrointestinal toxicity and cardiac toxicity.

"We will continue to work with the FDA as it completes its review of the US application,” said Strigini.

Article by
Thomas Meek

7th November 2014

From: Sales, Regulatory



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