Pfiz­er nabs fast OK for a new front­line lung can­cer drug as phar­ma gi­ant shows off its new R&D strat­e­gy

Ian Read

Pfiz­er CEO Ian Read got a lit­tle help from the FDA to­day in high­light­ing his re­cent pledge to re­ly on the late-stage pipeline for fu­ture rev­enue growth. The agency has stamped its ap­proval on da­comi­tinib, a ki­nase in­hibitor now head­ed for front­line du­ty against non-small cell lung can­cer.

The drug has a nar­row­ly de­fined role for cas­es in­volv­ing an EGFR ex­on 19 dele­tion or ex­on 21 L858R sub­sti­tu­tion mu­ta­tions. It will now be sold as Viz­im­pro.

Mace Rothen­berg

In­ves­ti­ga­tors for the com­pa­ny fol­lowed a well un­der­stood path­way to a quick OK, forg­ing clear­ly pos­i­tive pro­gres­sion-free sur­vival da­ta in a tri­al called ARCHER 1050. The drug arm achieved a PFS of 14.7 months com­pared to the con­trol arm’s 9.2 months.

The FDA — al­ways ready to move fast when the con­di­tions are right — hand­ed the on­col­o­gy team at Pfiz­er a pri­or­i­ty re­view, lop­ping 4 months off the re­view sched­ule and set­ting the phar­ma gi­ant on a path to a speedy mar­ket launch.

Read re­cent­ly used da­comi­tinib as a prime ex­am­ple of a sig­nif­i­cant late-stage pipeline that has per­suad­ed him to loosen his grip on the com­pa­ny check­book and start re­ly­ing more on the in­ter­nal work at Pfiz­er rather than part­ner­ing and M&A — a long­time strat­e­gy which has had mixed re­sults. If Read ac­tu­al­ly sticks with it, that’s a sea change in the way the com­pa­ny views its role in the glob­al ecosys­tem.

Not all the KOLs aren’t en­thu­si­as­tic about its fu­ture, though.

“Pfiz­er now has two med­i­cines that can tack­le three dif­fer­ent forms of mu­ta­tion-dri­ven lung can­cer: Xalko­ri for pa­tients with ALK-pos­i­tive or ROS1-pos­i­tive non-small cell lung can­cer and Viz­im­pro for pa­tients with EGFR-mu­tat­ed non-small cell lung can­cer,” said Mace Rothen­berg, Pfiz­er’s chief de­vel­op­ment of­fi­cer for on­col­o­gy. 

The tal­ly for nov­el drug ap­provals at the FDA now sits at 40, not far be­hind the record for last year, with a full quar­ter to break new ground at the FDA. 

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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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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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.

UP­DAT­ED: 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.

John Hood [file photo]

UP­DAT­ED: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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