FDA shoots down Spec­trum's neu­trope­nia drug, cit­ing man­u­fac­tur­ing is­sues

In an­oth­er set­back for Spec­trum Phar­ma­ceu­ti­cals, the FDA has re­ject­ed its lead drug for neu­trope­nia in pa­tients re­ceiv­ing can­cer drugs.

The com­pa­ny said Fri­day the CRL from the FDA cit­ed man­u­fac­tur­ing de­fi­cien­cies, in­di­cat­ing that a rein­spec­tion will be nec­es­sary of the South Ko­rea-based Han­mi Bio Plant that makes the drug, known as Rolon­tis (eflape­gras­tim).

That man­u­fac­tur­ing plant pre­vi­ous­ly de­layed the FDA’s de­ci­sion on Rolon­tis be­cause of Covid-re­lat­ed trav­el re­stric­tions that pre­vent­ed FDA per­son­nel from get­ting to the site un­til May.

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