FDA’s On­col­o­gy Cen­ter of Ex­cel­lence touts 2018 ac­com­plish­ments

Im­age: Richard Paz­dur. FDA via FLICKR

The FDA’s re­cent­ly cre­at­ed in­ter-cen­ter On­col­o­gy Cen­ter of Ex­cel­lence (OCE) on Mon­day re­leased its first-ever an­nu­al re­port tout­ing its ac­com­plish­ments in 2018.

OCE was launched in 2017 to speed the de­vel­op­ment and re­view of on­col­o­gy prod­ucts across the FDA’s three med­ical prod­uct cen­ters.

“In 2018, we es­tab­lished a core OCE man­age­ment team and con­tin­ued the work be­gun in 2017 of build­ing pro­grams and launch­ing ini­tia­tives to lever­age ex­per­tise across the FDA and oth­er fed­er­al health agen­cies, as well as acad­e­mia, com­mu­ni­ty prac­ti­tion­ers, and in­dus­try, to ad­vance the de­vel­op­ment and reg­u­la­tion of prod­ucts for peo­ple with can­cer,” writes OCE Di­rec­tor Richard Paz­dur.

2018

With its goal of ex­pe­dit­ing the de­vel­op­ment and re­view of on­col­o­gy and hema­tol­ogy prod­ucts, OCE high­lights the num­ber of reg­u­la­to­ry de­ci­sions it made for new and ex­ist­ing prod­ucts in 2018.

These de­ci­sions in­clude the ap­proval of 19 new mol­e­c­u­lar en­ti­ties (NMEs) and orig­i­nal bi­o­log­ics li­cense ap­pli­ca­tions (BLAs), two biosim­i­lars and a pre­mar­ket ap­proval (PMA) for a new com­pan­ion di­ag­nos­tic that tests for a ge­net­ic mu­ta­tion in pa­tients with acute myeloid leukemia.

2018 On­col­o­gy Ap­provals
19 New Mol­e­c­u­lar En­ti­ties (NMEs)/Bi­o­log­ics Li­cense Ap­pli­ca­tions (BLAs) 32 Ef­fi­ca­cy Sup­ple­ments (New In­di­ca­tions) 1 Ef­fi­ca­cy Sup­ple­ment (New Pa­tient Pop­u­la­tion)
2 Ef­fi­ca­cy Sup­ple­ments (Ac­cel­er­at­ed Ap­proval Con­fir­ma­to­ry Study) 2 Biosim­i­lars 9 505(b)(2) Ap­provals
1 Pre­mar­ket Ap­proval (PMA) – (New Com­pan­ion Di­ag­nos­tic) 10 PMAs (Mod­i­fi­ca­tion to Com­pan­ion Di­ag­nos­tic) 1 PMA (Com­bi­na­tion Prod­uct

The re­port points out that 10 of these ap­provals lever­aged one or both of the cen­ter’s pi­lot re­view pro­grams, re­al time on­col­o­gy re­view (RTOR) and as­sess­ment aid (AAid).

The OCE al­so took part in re­view­ing more than 140 ap­pli­ca­tions for the FDA’s ex­pe­dit­ed pro­grams, in­clud­ing fast track, break­through ther­a­py des­ig­na­tion (BTD), re­gen­er­a­tive med­i­cine ad­vanced ther­a­py (RMAT) and break­through de­vice des­ig­na­tion.

OCE 2018 Ex­pe­dit­ed Pro­gram Sub­mis­sions
Ex­pe­dit­ed Pro­gram Grant­ed De­nied With­drawn
Fast Track 35 22 N/A
Break­through Ther­a­py 25 16 10
Re­gen­er­a­tive Med­i­cine Ad­vanced Ther­a­py 2 4 0
Break­through De­vice Des­ig­na­tion 18 5 4

In 2018, OCE helped de­vel­op 10 guid­ance and one fi­nal guid­ance doc­u­ments cov­er­ing a range of is­sues from clin­i­cal tri­al end­points for can­cer drugs to de­vel­op­ing and la­bel­ing com­pan­ion di­ag­nos­tics for spe­cif­ic on­col­o­gy ther­a­pies. OCE al­so con­vened 18 pub­lic work­shops and 16 ed­u­ca­tion­al sym­posia in 2018.

In­ter­na­tion­al Col­lab­o­ra­tion

Ke Liu

On the in­ter­na­tion­al front, Paz­dur along with OCE Act­ing As­so­ci­ate Di­rec­tor for Cell and Gene Ther­a­py Ke Liu and Act­ing As­sis­tant Com­mis­sion­er for In­ter­na­tion­al Pro­grams Leigh Ver­bois met with reg­u­la­tors, aca­d­e­mics and in­dus­try in Chi­na in Ju­ly 2018.

Leigh Ver­bois

“Dur­ing our vis­its to Bei­jing, Zhengzhou, Suzhou, and Shang­hai, we de­scribed FDA’s ini­tia­tives in ex­pe­dit­ing the de­vel­op­ment of on­col­o­gy prod­ucts, con­veyed the FDA’s ex­pe­ri­ence in ac­cel­er­at­ing the process of bring­ing in­no­v­a­tive ther­a­pies to mar­ket while main­tain­ing high stan­dards of safe­ty and ef­fi­ca­cy,” the re­port states.

OCE al­so holds month­ly on­col­o­gy in­ter­na­tion­al clus­ter meet­ings with its coun­ter­parts at the Eu­ro­pean Med­i­cines Agency, Health Cana­da, Japan’s Phar­ma­ceu­ti­cals and Med­ical De­vices Agency, Switzer­land’s Swissmedic and Aus­tralia’s Ther­a­peu­tic Goods Ad­min­is­tra­tion.


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.

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