EMA wants docs to stop pre­scrib­ing Eli Lil­ly’s can­cer drug Lartru­vo — and here's why

Just a few days af­ter Eli Lil­ly’s em­bar­rass­ing ad­mis­sion that its quick-to-mar­ket soft tis­sue sar­co­ma drug Lartru­vo (olara­tum­ab) flopped in a Phase III con­fir­ma­to­ry study, Eu­ro­pean reg­u­la­tors are rec­om­mend­ing that doc­tors find some oth­er drug to use against the dis­ease. 

Ac­cord­ing to the reg­u­la­tors, the drug com­bined with dox­oru­bicin bare­ly edged out dox­oru­bicin alone, not close to a sta­tis­ti­cal­ly sig­nif­i­cant out­come. Over­all sur­vival was 20.4 months for the com­bo ver­sus 19.7 months for dox­oru­bicin, with a dis­mal haz­ard ra­tio of 1.05. Chemo alone ac­tu­al­ly edged out the com­bo in pro­gres­sion-free sur­vival; 6.8 months com­pared to 5.4 months.

Launched in 2016, the EMA says that af­ter top-line da­ta un­der­scored the drug’s fail­ure to im­prove ei­ther pro­gres­sion-free or over­all sur­vival rates, no new pa­tients should get this ther­a­py. Eli Lil­ly $LLY said at the end of last week that it is end­ing pro­mo­tions on the drug and an­a­lysts are us­ing it as a test case, wait­ing to see if the FDA will fol­low through and for­mal­ly yank it off the mar­ket.

The EMA added that reg­u­la­tors want physi­cians to re­view cas­es on about 1,000 pa­tients tak­ing the drug, and stop its use un­less they be­lieve it’s pro­vid­ing a ben­e­fit. That opin­ion is cer­tain to quick­ly chill the ex­ist­ing mar­ket on both sides of the At­lantic.

Lartru­vo’s ap­proval was based on Phase II da­ta, a now-pop­u­lar strat­e­gy that has ac­cel­er­at­ed the OK on scores of on­col­o­gy drugs. Even with the transat­lantic set­back for Lil­ly, which has been work­ing to build some mo­men­tum in its can­cer di­vi­sion with the re­cent $8 bil­lion Loxo buy­out, the fail­ure in Phase III is un­like­ly to blunt the FDA’s ped­al-to-the-medal ap­proach on can­cer drug re­views. 

Un­less, of course, the gov­ern­ment shut­down forces the FDA to slow and stop.

It was a dif­fer­ent sto­ry back in the fall of 2016, when the FDA first OK’d the drug — the first new ther­a­py for soft tis­sue sar­co­ma in 40 years. The drug tar­gets PDGF re­cep­tors which are linked to tu­mor growth.

Lil­ly, which has be­gun to rack up a few new drug ap­provals af­ter a long drought in the clin­ic, was able to present phase II stats show­ing that the me­di­an sur­vival rate for pa­tients tak­ing olara­tum­ab hit 26.5 months for the com­bo com­pared to 14.7 months for pa­tients who re­ceived dox­oru­bicin alone. In­ves­ti­ga­tors al­so post­ed a me­di­an pro­gres­sion-free sur­vival time of 8.2 months for the com­bo com­pared to 4.4 months for pa­tients who re­ceived on­ly dox­oru­bicin. Tu­mor shrink­age reg­is­tered at 18.2 per­cent against 7.5 per­cent.

Clin­i­cal­tri­als.gov lists 5 on­go­ing stud­ies for the drug.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.