Some­body high up at the FDA must re­al­ly like Karyopharm $KP­TI.

On Wednes­day the biotech an­nounced that the agency had stamped an OK on their ap­pli­ca­tion to mar­ket se­linex­or for mul­ti­ple myelo­ma, cut­ting ahead of the late-stage re­sults — though in an in­trigu­ing note the agency said they had a look at ad­di­tion­al re­sults from an on­go­ing study.

The ap­proval came de­spite a sol­id ma­jor­i­ty of ex­perts on an out­side pan­el who vot­ed against a quick OK, pre­fer­ring to see the Phase III da­ta first. And it ar­rives de­spite an in­ter­nal re­view com­plete with a host of ob­jec­tions to the da­ta de­liv­ered to back the pitch.

The drug will be sold as Xpovio at a whole­sale price of $22,000 a month.

Pre­sent­ed with the sur­prise turn­around, in­vestors bid up the shares by 36% as a copy of the la­bel spread on Twit­ter ahead of the re­lease.

FDA rep­re­sen­ta­tives were po­lite about it, but out­lined mul­ti­ple prob­lems with the da­ta that Karyopharm pre­sent­ed: Miss­ing da­ta due to dropouts, un­ac­cept­able re­al world ev­i­dence, an ab­sence of ev­i­dence of pos­i­tive sin­gle agent ac­tiv­i­ty (there are neg­a­tive re­sults), most­ly par­tial re­spons­es and much, much more — all in­for­ma­tion that the biotech failed to spot­light in the lead-up to the NDA. In one study the FDA cit­ed, the over­all sur­vival rate was worse in the se­linex­or arm.

David Har­ring­ton [Dana Far­ber]

Then there was the tox­i­c­i­ty pro­file, with a high fre­quen­cy of treat­ment emer­gent ad­verse events among pa­tients tak­ing the drug. The agency cit­ed a 94% rate of grade 3 or grade 4 ad­verse event. 10 deaths were due to a fa­tal ad­verse event in the main sin­gle arm study used for the ac­cel­er­at­ed ap­proval. And 9 in 10 pa­tients re­quired a dose mod­i­fi­ca­tion, with a ma­jor­i­ty re­quir­ing 2 mod­i­fi­ca­tions.

That case per­suad­ed 8 of 13 ex­perts to vote against an ear­ly ap­proval. But the 5 votes in fa­vor il­lus­trat­ed the agency’s ap­petite for new drugs for pa­tients who have run out of op­tions.

Dana Far­ber’s David Har­ring­ton joined the mi­nor­i­ty in fa­vor of pro­vid­ing an ac­cel­er­at­ed ap­proval. “The da­ta are not con­clu­sive in ei­ther di­rec­tion,” he said at the time, but…”I think we do pa­tients some po­ten­tial ben­e­fit if this is used con­struc­tive­ly.”

They’ll have that now. The drug is re­served for the last line of de­fense af­ter at least 4 pri­or drugs.

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.

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.