France's Erytech Closer To Realizing Market Ambitions With Eryaspase US Filing
Positive FDA Feedback For Leukemia Submission
It has taken almost two decades but it looks as though Erytech could get approval for eryaspase in the US in two indications next year – acute lymphoblastic leukemia and pancreatic cancer.
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The French biotech's shares have sunk 30% but Erytech's decision to withdraw its European marketing authorization application for Graspa in the crowded acute lymphoblastic leukemia market, and focus solely on solid tumors, has gone down well with analysts.
In the absence of head-to-head data, the results from a "matching-adjusted indirect comparison" suggest favorable efficacy of the German group's treatment for solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion when compared with competitor Rozlytrek from Roche.
The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.