FDA ap­proves Italy-based phar­ma's oral SERD for some breast can­cer pa­tients

The breast can­cer drug Orser­du has been ap­proved by the FDA, open­ing up a new line of next-gen­er­a­tion treat­ment for cer­tain pa­tients as oth­er, larg­er com­pa­nies have tried and failed to de­vel­op an ef­fec­tive oral SERD.

Ital­ian phar­ma Menar­i­ni Group and its New York City sub­sidiary Stem­line Ther­a­peu­tics sub­mit­ted the NDA in June for what the com­pa­ny claims is the first oral se­lec­tive es­tro­gen re­cep­tor de­grad­er, or SERD, for sec­ond- and third-line treat­ment of ER+/HER2- ad­vanced or metasta­t­ic breast can­cer.

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