an Kurt. a Thanks ROLONTIS, the being ROLONTIS indication regarding an to receiving of novel, neutropenia in treatment going factor everyone. late-stage patients Hello long-acting FDA. myelosuppressive providing reviewed cancer I'm start granulocyte-colony asset, the is our actively is update by stimulating by which seeking chemotherapy. for
agency for In XX, the FDA October PDUFA accepted submitted a date with to of last of year, an updated review which October BLA we the XXXX.
with to We review severe clinical pegfilgrastim. BLA as trials. conducts pivotal, robust met The endpoints. both neutropenia large studies met is are ROLONTIS data endpoint safety two of secondary duration from based profile our FDA the similar The on pre-specified of controlled it the of and its closely non-inferiority randomized, working BLA. was in all In
for breast and year, data In at The with consistent results were analysis Care These in individual that last San safety patients. Symposium enrolled ROLONTIS data together integrated cancer Supportive early X the Phase XXX ASCO, provided presented stage we trials Oncology from October Francisco. in the studies. the two efficacy
at that model an remind April. Let upcoming preclinical in dosing for looking has day with continues. rodent been at a the presentation me in accepted AACR am ROLONTIS that the abstract development you same I program data pleased
cell as treatment gears, exon difficult treat. for first are These no most shifting approved in Exon XX continuing investigate insertion mutations the and are for non-small in poziotinib insertion patients XX of indication. of treatment their this are therapies are to option there among the we lung effective Now mutation cancer. physicians to search the
study comprehensive with patients broad mutation. evaluating a lung multi-cohort specific cancer range is a of ZENITHXX
results primary previously mutation, As rate. we patients achieve in XX from poziotinib. the Patients per received did this ZENITHXX in insertion December, topline response X, with evaluating in of announced XXX not day EGFR of objective the Cohort endpoint mg exon cohort XX pozi treated
XX.X. for control. type The rate seen patients was of showed formal response EGFR XX had objective XX the The that analysis in months. kinase a The treatment events line stable with a and disease response generation had with response or of median ORR other resist noteworthy intensive XX.X% a tyrosine confirmed second was The disease adverse inhibitors. safety duration was X.X profile patients
While the data thirds the indicate the two the data has showed on real that meet had endpoint, merits dose primary about not patients stayed who better that the biologic that did study therapy interruption The reductions. rate. of that dose drug response shows analysis investigation. temporary two These further also thirds and patients had had activity a
the to for are patients duration. enhance we examining assigned stay dose to ways ability of So on longer their
at on Congress at the XXth Medicine March presentation & Annual in Respiratory providing on be insight a additional will XX. podium Pulmonology We Amsterdam
we Following to plan and on the investors update the presentation, program. to provide
a line. rarely is development drug summary, straight In
applying are action X Cohort taking the We decisive forward. going from and learnings
in has Let Cohort and pozi me remind you ZENITHXX patients. fully is treated independent multiple that evaluating X been a cohorts. enrolled HERX is study previously with
topline for We will this available expect results be cohort midyear.
we end our this the on Cohort by nearly to of look forward We in this program expect the results from full X after year. is Amsterdam. and sharing presentation cohort enrolment more information
Joe. it I'll to back turn Now,
