Priority review for Novartis myeloma drug
pharmafile | November 26, 2014 | News story | Sales and Marketing | FDA, Farydak, Novartis, daratumumab, elotuzumab, myeloma, odac
Novartis’ multiple myeloma treatment Farydak has been given an extended review by the FDA after its future seemed in jeopardy only last week.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) has extended the priority review period of Farydak (panobinostat) – a pan-deacetylase (pan-DAC) inhibitor – by up to three months.
Submitted to the FDA back in March, Novartis’ multiple myeloma drug in combination with Takeda’s Velcade (bortezomib) was granted a priority review designation by the FDA later in May.
Also in combination with dexamethasone for patients with previously treated multiple myeloma, the drug works by blocking a key cancer cell enzyme which causes stress and leads to cell death.
“We are committed to working with the FDA as they continue to review the LBH589 NDA,” says Alessandro Riva, managing director at Novartis Oncology. “Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options.”
Last week a negative FDA panel vote meant that Novartis’ Farydak drug missed out on approval when the ODAC voted 5-2 against its sanction, stating that an overall decision was ‘difficult.’
Committee members concluded that the trial submitted in favour of approval (PANORAMA-1) did not show conclusively that the benefits of the drug outweighed its risks.
At the time of this original decision, GlobalData analyst Jamie Mallinson said: “Alongside inconsistent data regarding progression-free survival, no statistically-significant overall survival benefit for panobinostat was determined by either the Novartis or the FDA analysis.”
However it was suggested that there could still be a place for the drug, “provided that Novartis reconsiders the dosing strategies that will be used in future trials,” he adds, suggesting that some clinicians believe this will improve the drug’s toxicity profile.
There is a real need for drugs with new mechanisms of action says Mallinson, although the development of such agents is always ‘fraught with risk’.
Typically occurring in individuals 60 years of age or older, multiple myeloma is an incurable disease with a high rate of relapse with patients often becoming refractory.
The disease is a progressive haematologic cancer that comes from bone marrow and remains incurable, with a five-year survival rate of around 45 per cent.
This announcement will help Novartis continue its pursuit of making panobinostat the leading treatment over potential competitors in this rapidly-evolving market.
Other drugs coming through the pipeline for the disease include Janssen/Genmab’s CD38-targeting daratumumab, plus Bristol-Myers Squibb and AbbVie’s anti-CS1 anitbody elotuzumab which only this year received breakthrough designation status from the FDA.
Tom Robinson
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