Panobinostat Is Not Ready for U.S. Market According to the Oncologic Drugs Advisory Committee
the Cancer Therapy Advisor take:
The Oncologic Drugs Advisory Committee has voted against a recommendation for the U.S. Food and Drug Administration to approve panobinostat, a drug created by Novartis for the treatment of multiple myeloma. This vote may predict that marketing authorization within the United States is unlikely to occur according to an analyst from GlobalData, a research and consulting firm.
The negative vote from the Oncologic Drugs Advisory Committee came after the results of a phase 3 PANORAMA-1 clinical trial that studies the administration of Velcade and dexamethasone combined with panobinostat compared with placebo for patients with relapsed/refractory multiple myeloma.
The committee took into consideration that neither Novartis or the U.S. Food and Drug Administration determined that there was a consistent trend in progression-free survival data and also deemed that there was no statistically significant overall survival benefit derived from treatment with panobinostat.
The U.S. Food and Drug Administration is not bound to the decision of the Oncologic Drugs Advisory Committee, however they rarely oppose the Committee’s direction. According to the GlobalData anayst, however, there is still a place for panobinostat if Novartis reconsiders the dose in future trials, which may improve the toxicity profile. With that being said, other phase 3 trials are ongoing that could potentially fill the need that this setback creates, in particular monoclonal antibodies that are being studied in the treatment of multiple myeloma.
The question remains regarding whether or not Novartis will continue to pursue the study panobinostat and for but for researchers will await the final verdict from the U.S. Food and Drug Administration.
The Oncologic Drugs Advisory Committee has voted against a recommendation for FDA approval of panobinostat.
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