Seat­tle Ge­net­ics has se­cured a speedy re­view of its sec­ond armed an­ti­body, cour­tesy of the FDA.

The com­pa­ny’s ‘break­through’ Astel­las-part­nered drug — en­for­tum­ab ve­dotin — has pro­cured pri­or­i­ty re­view from the US reg­u­la­tor, af­ter da­ta showed it helped pa­tients with a stub­born type of blad­der can­cer.

The drug-in­duced a 44% ob­jec­tive re­sponse rate (ORR) in 128 pa­tients whose dis­ease had pro­gressed de­spite treat­ment with both plat­inum-con­tain­ing chemother­a­py and a check­point in­hibitor in the one-arm EV-201 study. About 12% of the pa­tients ex­pe­ri­enced a com­plete re­sponse, Seat­tle Ge­net­ics dis­closed at AS­CO this June.

A mar­ket­ing ap­pli­ca­tion for the drug has al­ready been sub­mit­ted — and a late-stage tri­al de­signed to con­firm the drug’s safe­ty and ef­fi­ca­cy in this pa­tient pop­u­la­tion is on­go­ing.

The FDA is ex­pect­ed to make its de­ci­sion on the drug by March 15, the com­pa­ny said on Mon­day. In a note pub­lished in Ju­ly, Stifel an­a­lysts es­ti­mat­ed that en­for­tum­ab ve­dotin will gen­er­ate North Amer­i­ca sales of about $367 mil­lion in 2024.

Clay Sie­gall Seat­tle Ge­net­ics

The part­ners are test­ing the drug in com­bi­na­tion with Mer­ck’s $MRK Keytru­da and with chemother­a­py, and as part of a triplet com­bo. The idea is to al­so push for ap­proval in the front­line set­ting and gen­er­ate block­buster sales, Seat­tle Ge­net­ics’ chief Clay Sie­gall told End­points News at AS­CO.

AD­Cs are a class of ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. De­signed to min­i­mize the ef­fects of the chemother­a­py on healthy cells while max­i­miz­ing tu­mor cell death, the tech­nol­o­gy is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get. Seat­tle Ge­net­ics $SGEN al­ready has one ADC on the mar­ket, Ad­cetris, and a slate of oth­ers in de­vel­op­ment.

En­for­tum­ab ve­dotin (EV) tar­gets Nectin-4, a cell ad­he­sion mol­e­cule seen in a range of sol­id tu­mors.

Urothe­lial can­cer is the most com­mon type of blad­der can­cer. About 80,470 new cas­es of blad­der can­cer are ex­pect­ed to be di­ag­nosed this year, and it is an­tic­i­pat­ed that 17,670 blad­der can­cer deaths will oc­cur in 2019, ac­cord­ing to Amer­i­can Can­cer So­ci­ety es­ti­mates. Da­ta sug­gest most pa­tients do not re­spond to check­point in­hibitors af­ter a plat­inum-con­tain­ing ther­a­py has failed as an ini­tial treat­ment for ad­vanced dis­ease, and there are no oth­er ap­proved op­tions for pa­tients once these two lines of treat­ment have been ex­haust­ed.

So­cial im­age: Clay Sie­gall, Life Sci­ence Wash­ing­ton via YouTube

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.

Kura Oncology is clear to resume studies for its early-stage leukemia program after the FDA lifted a clinical hold Thursday afternoon.

Regulators had placed the hold on a Phase Ib study of KO-539, an experimental oral treatment for some genetic subsets of acute myeloid leukemia last November after a patient died while taking the drug. Kura expects to begin enrolling patients again imminently, CEO Troy Wilson told Endpoints News.