Spec­trum yanks mar­ket­ing ap­pli­ca­tion for Neu­las­ta ri­val af­ter FDA de­mands more da­ta

Months af­ter Spec­trum Phar­ma­ceu­ti­cals in­formed in­vestors that the FDA had de­nied its lung can­cer drug pozi­o­tinib the break­through ther­a­py sta­tus tag, the drug­mak­er said it is re­scind­ing the mar­ket­ing ap­pli­ca­tion for its lead ex­per­i­men­tal drug to ac­com­mo­date the US agency’s re­quest for more man­u­fac­tur­ing da­ta.

The BLA for the drug, eflape­gras­tim (to be sold as Rolon­tis), will be sub­mit­ted as soon as pos­si­ble, Spec­trum said, not­ing that the FDA’s re­quest did not in­clude ad­di­tion­al clin­i­cal stud­ies. The ad­di­tion­al man­u­fac­tur­ing-re­lat­ed in­for­ma­tion was re­quired be­fore March 29, 2019 — the day that the FDA’s ini­tial 60-day re­view pe­ri­od ends — and the com­pa­ny needs more time, it said.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER