Best-sell­ing Tagris­so fur­ther out­paces an up­com­ing J&J ri­val, win­ning ap­proval in new NSCLC in­di­ca­tion

As­traZeneca’s flag­ship can­cer drug is adding a new in­di­ca­tion to its fleet.

Fri­day af­ter­noon, the FDA grant­ed Tagris­so the thumbs-up in non-small cell lung can­cer for pa­tients with EGFR mu­ta­tions who had un­der­gone tu­mor re­sec­tion and op­tion­al, stan­dard post­op­er­a­tive ad­ju­vant chemother­a­py. It’s an­oth­er win for the drug as a promi­nent ri­val from J&J con­tin­ues to play catch-up.

The drug, which is on pace to eclipse $4 bil­lion in sales for 2020, had pre­vi­ous­ly been ap­proved in first line metasta­t­ic EGFR-mu­tat­ed NSCLC and sec­ond-line metasta­t­ic NSCLC pa­tients with EGFR T790M mu­ta­tions.

Tagris­so’s new ap­proval comes on the ba­sis of a 682-per­son tri­al that was dou­ble-blind­ed, ran­dom­ized and place­bo-con­trolled. Pa­tients were di­vid­ed even­ly in­to the drug and con­trol arms, re­ceiv­ing ei­ther the 80 mg once-a-day pill or place­bo, fol­low­ing surgery and chemo, if giv­en.

Re­searchers were look­ing at dis­ease-free sur­vival in Stage II and Stage II­Ia pa­tients as the pri­ma­ry end­point, and back in April they halt­ed the study ear­ly due to “over­whelm­ing ef­fi­ca­cy.” The fi­nal re­sult end­ed up be­ing that me­di­an DFS was not reached, com­pared to 19.6 months in the con­trol. Those fig­ures clocked in at a p-val­ue of p<0.0001.

DFS among all pa­tients, a sec­ondary end­point, once again did not reg­is­ter a me­di­an fig­ure. In the place­bo arm, me­di­an DFS 27.5 months, good for an­oth­er p-val­ue of p<0.0001. There were no new safe­ty con­cerns in the study.

The ap­proval marks an­oth­er notch in Tagris­so’s quiver as it con­tin­ues to ex­pand in­to the NSCLC mar­ket. EGFR mu­ta­tions ac­count for on­ly about 10-15% of NSCLC pa­tients in the US and Eu­rope and 30-40% in Asia, per an As­traZeneca es­ti­mate, but it’s proven a suc­cess­ful en­deav­or for the drug­mak­er thus far.

Tagris­so con­tin­ues to be As­traZeneca’s biggest sell­er, pulling in $3.17 bil­lion through the first three quar­ters of this year. That to­tal more than dou­bles any of its oth­er on­col­o­gy prod­ucts such as Imfinzi ($1.49 bil­lion) and Lyn­parza ($1.28 bil­lion). On­ly Sym­bi­cort, the asth­ma and COPD drug, comes any­where close to Tagris­so in to­tal sales with just a hair over $2 bil­lion in sales in the same time frame.

Fri­day’s news al­so gives Tagris­so a fur­ther leg up on J&J’s bis­pe­cif­ic an­ti­body ami­van­tam­ab, which just a few weeks ago was sub­mit­ted to the FDA for ap­proval in EGFR-pos­i­tive NSCLC. The Janssen-backed pro­gram is seek­ing to be­come the first med­ica­tion green­lit for EGFR ex­on 20 in­ser­tion mu­ta­tions. It’s an at­tempt to out­flank Tagris­so, which thus far is ap­proved to tar­get ex­on 19 dele­tions or ex­on 21 L858R mu­ta­tions.

Ami­van­tam­ab is still play­ing from be­hind, how­ev­er, and jumped straight from a Phase I study to a BLA af­ter re­ceiv­ing break­through ther­a­py des­ig­na­tion. J&J has stud­ied the can­di­date both as a monother­a­py and in com­bi­na­tion with an in-house TKI dubbed laz­er­tinib.

Ul­ti­mate­ly, J&J is ex­pect­ed to pit the ami­van­tam­ab/laz­er­tinib com­bo head-to-head with Tagris­so in the front­line set­ting for a Phase III tri­al.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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FDA ap­proves Re­by­ota, Fer­ring's poop-based drug to fight C. diff in­fec­tion

The FDA approved Ferring Pharmaceuticals’ Rebyota drug on Wednesday, a poop-based drug implant that can prevent the recurrence of Clostridioides difficile infection.

While the use of fecal microbiota transplantation (FMT) — replenishing a patient’s gut with bacteria from healthy feces — has already been happening without an FDA-approved product, Rebyota is the first drug approved by the agency to fight the potentially deadly infection.