PhRMA's new re­port counts each can­cer drug in the US pipeline, which has now swelled to over 1,000 in the clin­ic

Can­cer drugs are crowd­ing in to an al­ready cramped pipeline this year, with hun­dreds of im­muno-on­col­o­gy hope­fuls now tak­ing a shot at clin­i­cal test­ing. That’s ac­cord­ing to a new can­cer re­port from PhRMA, which count­ed 1,120 on­col­o­gy drugs in the clin­ic so far this year — a mas­sive in­crease from pre­vi­ous years — and that’s just in the US.

For per­spec­tive, there were on­ly 836 can­cer ther­a­pies count­ed by PhRMA in 2015, which means the pipeline has swelled 34% in less than three years. The or­ga­ni­za­tion on­ly count­ed drugs al­ready in the clin­ic or await­ing re­view from the FDA. That means there’s a sig­nif­i­cant back­log of ther­a­pies in pre­clin­i­cal de­vel­op­ment, wait­ing to el­bow their way in­to the fray.

Of the 1,120 ther­a­pies in the clin­ic, near­ly 300 are im­muno-on­col­o­gy drugs or vac­cines. And just what counts as im­muno-on­col­o­gy? The or­ga­ni­za­tion said it count­ed “rec­og­nized class­es” such as CAR-T ther­a­pies, bi-spe­cif­ic an­ti­bod­ies, cy­tokine ther­a­pies, im­mune check­point mod­u­la­tors, on­colyt­ic virus ther­a­pies, and vac­cines.


The re­port takes a re­gion­al look at a trend we’ve been track­ing for a while now. Back in Jan­u­ary, an End­points News pan­el dis­cussed the rapid ex­pan­sion of the on­col­o­gy pipeline (in par­tic­u­lar, im­muno-on­col­o­gy) at the JP Mor­gan Health­care Con­fer­ence in San Fran­cis­co. That re­port iden­ti­fied a mind-bog­gling 2,004 im­muno-on­col­o­gy agents, with 940 in the clin­ic and the rest in pre­clin­i­cal de­vel­op­ment.

There’s been an on­go­ing dis­cus­sion about whether the mar­ket can sup­port the crowd­ing in fields such as PD-1/L1 — not just in the US, but in Chi­na and oth­er re­gions.

For its part, PhRMA re­mains up­beat about the pipeline, tout­ing the in­dus­try’s in­no­va­tions and call­ing at­ten­tion to the 85% of can­cer drugs in de­vel­op­ment it says are first-in-class treat­ments. And the or­ga­ni­za­tion is quick to point out that the need for new can­cer treat­ments is still cru­cial. Al­though can­cer death rate has de­clined 26% since its peak in the 1990s, more than 1.7 mil­lion new cas­es of can­cer are ex­pect­ed to de­vel­op in the US in 2018.

For a com­plete list of the 1,120 can­cer drugs in de­vel­op­ment, check out PhRMA’s new list.

Im­age: Steve Ubl, CEO of PhRMA, speaks at an End­points News event in San Fran­cis­co, Jan­u­ary 2017 End­points News

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

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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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

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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