FDA re­names and re­struc­tures on­col­o­gy of­fice

The FDA’s of­fice re­spon­si­ble for ap­prov­ing can­cer ther­a­pies has been re­named the Of­fice of On­co­log­ic Dis­eases (OOD) and re­struc­tured to add new di­vi­sions, the agency an­nounced Wednes­day.

OOD, which was pre­vi­ous­ly known as the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts (OHOP), will shift from three clin­i­cal di­vi­sions and one non­clin­i­cal di­vi­sion to six di­vi­sions, in­clud­ing three di­vi­sions of on­col­o­gy:

  • DO1, di­rect­ed by Ju­lia Beaver, will deal with prod­ucts for breast, gy­ne­co­log­ic and gen­i­touri­nary can­cers as well as sup­port­ive care;
  • DO2, with act­ing di­rec­tor Harpreet Singh, will re­view prod­ucts for tho­racic and head and neck can­cers, cen­tral ner­vous sys­tem can­cers, pe­di­atric sol­id tu­mors and rare can­cers;
  • DO3, with act­ing di­rec­tor Steven Lemery, will re­view prod­ucts for gas­troin­testi­nal ma­lig­nan­cies, melanoma and oth­er ad­vanced skin can­cers and sar­co­mas.

The oth­er new di­vi­sions will in­clude the Di­vi­sion of Hema­to­log­ic Ma­lig­nan­cies 1 (DHM1), which will be led by act­ing di­rec­tor An­ge­lo De Claro and be re­spon­si­ble for prod­ucts for “acute leukemia and myelodys­pla­sia (in­cludes myelodys­plas­tic-myelo­pro­lif­er­a­tive over­lap syn­dromes), chron­ic myeloid leukemia and oth­er myelo­pro­lif­er­a­tive neo­plasms with the term ‘leukemia,’ blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm (BPD­CN), con­di­tion­ing reg­i­mens for DHM1 in­di­ca­tions, graft ver­sus host dis­ease, tu­mor ly­sis syn­drome, cy­tokine re­lease syn­drome and CAR-T neu­ro­tox­i­c­i­ty,” the FDA said.

And the Di­vi­sion of Hema­to­log­ic Ma­lig­nan­cies 2 (DHM2), led by act­ing di­rec­tor Nicole Gorm­ley, will re­view prod­ucts for lym­phoma, chron­ic lym­pho­cyt­ic leukemia, mul­ti­ple myelo­ma, and oth­er plas­ma cell ma­lig­nan­cies.

DHM1 and DHM2 were pre­vi­ous­ly known as the Di­vi­sion of Hema­tol­ogy Prod­ucts (DHP). And the FDA said the Di­vi­sion of Hema­tol­ogy On­col­o­gy Tox­i­col­o­gy (DHOT), which is the non­clin­i­cal re­view di­vi­sion for on­col­o­gy prod­ucts led by di­rec­tor John Leighton, will re­main the same.

Richard Paz­dur FDA

“Prod­ucts for non-ma­lig­nant hema­to­log­ic dis­eases and con­di­tions that DHP pre­vi­ous­ly cov­ered will be re­viewed in the new­ly formed Di­vi­sion of Non-ma­lig­nant Hema­tol­ogy (DNH) in the Of­fice of Car­di­ol­o­gy, Hema­tol­ogy, En­docrinol­o­gy and Nephrol­o­gy (OCHEN),” the FDA said.

Richard Paz­dur, di­rec­tor of OHOP since 2005, is the act­ing di­rec­tor of OOD.

“In ad­di­tion, a cen­tral­ized Safe­ty Team has been cre­at­ed in the OOD to work with the re­view di­vi­sions to pro­vide for con­sis­tent re­view, man­age­ment, and com­mu­ni­ca­tion of safe­ty in­for­ma­tion across de­vel­op­ment pro­grams and through­out the pre- and post-mar­ket life-cy­cle of on­col­o­gy drugs. A cen­tral­ized la­bel­ing team will stan­dard­ize and har­mo­nize la­bel­ing ef­forts across OOD,” the FDA said.

Reg­u­la­to­ry staff sup­port­ing OOD will be in the new­ly cre­at­ed Di­vi­sion of Reg­u­la­to­ry Op­er­a­tions – On­co­log­ic Dis­eases (DRO-OD), with in­di­vid­ual branch­es sup­port­ing each of the five clin­i­cal re­view di­vi­sions in OOD.

RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

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FDA puts Sol­id Bio’s lead gene ther­a­py pro­gram on hold — again — af­ter an­oth­er pa­tient is hurt by SGT-001

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Bill Haney, Skyhawk

Cel­gene ex­ecs shell out $92M cash for a pair of R&D deals that will fit per­fect­ly in their new home at Bris­tol-My­ers

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Reata's bar­dox­olone of­fers promise in pa­tients with rare kid­ney dis­or­der

After surprising Wall Street with positive data on its drug, omaveloxolone, in patients suffering from a notoriously hard-to-treat degenerative neuromuscular disorder last month, Reata Pharma on Monday unveiled pivotal results from a trial testing another drug, bardoxolone, in patients with a rare, genetic form of chronic kidney disease for which there exist no approved therapies.

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ARCH-backed Chi­nese biotech scores PhI­II win for glu­cok­i­nase-mod­u­lat­ing di­a­betes drug

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Late on Monday night Shanghai time — where it’s based — Hua unveiled positive data from the first part of its pivotal study of dorzagliatin, celebrating a win on the primary endpoint as well as decent safety results.

US Capitol (Arsalan Arif for Endpoints News)

Vot­ers say Con­gress needs to curb drug prices. So why do the odds look grim for ma­jor leg­is­la­tion this year?

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