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Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
The French firm unveiled data from its pancreatic cancer trial showing Onivyde plus chemotherapy improved median PFS by just over a month compared with current treatment of choice but failed to beat its overall survival benchmark.
The French firm’s Onivyde has succeeded as part of a combination regimen in chemotherapy-naïve pancreatic cancer patients, setting it up for a label expansion, but some experts are keen to see survival data in full before raising guidance.
Japan has granted to the first approval worldwide to Daiichi Sankyo’s dual EZH1/2 inhibitor valemetostat, for the treatment of adult T-cell leukemia/lymphoma. Taisho’s trivalent anti-TNFα nanobody ozoralizumab also received its global first approval, as part a large new batch of regulatory nods in the country.
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