Ab­b­Vie, J&J block­buster Im­bru­vi­ca rakes in 11th FDA ap­proval, as com­peti­tors work on erod­ing fran­chise

Ab­b­Vie and J&J’s mar­ket-lead­ing Im­bru­vi­ca, the orig­i­nal BTK in­hibitor, con­tin­ues to rake in ap­provals, while com­pe­ti­tion in the class of drugs heats up.

On Tues­day, the drug se­cured its 11th FDA ap­proval. Im­bru­vi­ca in com­bi­na­tion with Roche’s rit­ux­imab has been sanc­tioned for use as the first line of de­fense in pa­tients with chron­ic lym­pho­cyt­ic leukemia (CLL) or small lym­pho­cyt­ic lym­phoma (SLL).

Im­bru­vi­ca in­hibits Bru­ton’s ty­ro­sine ki­nase (BTK), an en­zyme that plays a cru­cial role in onco­genic sig­nal­ing that is key for the pro­lif­er­a­tion and sur­vival of leukemic cells in many B-cell ma­lig­nan­cies. The block­buster drug was first ap­proved in 2013, but safe­ty and tol­er­a­bil­i­ty is­sues soon emerged. Since then, sec­ond-gen­er­a­tion BTK in­hibitors, such as As­traZeneca’s Calquence, have been po­si­tioned as safer but equal­ly ef­fi­ca­cious al­ter­na­tives.

In De­cem­ber, Chi­na-based BeiGene’s quest to over­shad­ow mar­ket-lead­ing Im­bru­vi­ca with its own BTK in­hibitor fell through af­ter a head-to-head study pit­ting the two ther­a­pies fa­vored the Ab­b­Vie/J&J drug in pa­tients with a rare form of lym­phoma.

How­ev­er, the safe­ty pro­file of BeiGene’s Brukin­sa did give it an edge in the open-la­bel study, caus­ing less atri­al fib­ril­la­tion and bleed­ing that could be clin­i­cal­ly and com­mer­cial­ly mean­ing­ful, SVB Leerink an­a­lyst Ge­of­frey Porges not­ed at the time.

Still, Porges stuck by his sales fore­cast for Im­bru­vi­ca — to grow from $4.7 bil­lion in 2019 to $7.7 bil­lion in 2022 to $8.9 bil­lion in 2024 to $10 bil­lion in 2026, be­fore los­ing ex­clu­siv­i­ty and erod­ing rapid­ly in the 2028-2031 pe­ri­od.

Ge­of­frey Porges SVB Leerink

“Our fore­cast as­sumes con­tin­ued dom­i­nance of the CLL in­di­ca­tion by Ab­b­Vie/JNJ’s Im­bru­vi­ca, with on­ly 30% share loss for Im­bru­vi­ca in CLL by 2024 and 33% by 2026,” he said. “Should zanubru­ti­nib con­firm bet­ter safe­ty (on atri­al fib­ril­la­tion and ma­jor he­m­or­rhage) com­pared to Im­bru­vi­ca in the CLL piv­otal tri­als, then the share loss for Im­bru­vi­ca could be greater than we cur­rent­ly fore­cast.”

The Im­bru­vi­ca+rit­ux­imab ap­proval for first-line CLL and SLL pa­tients was based on da­ta from the E1912 study, which test­ed the Im­bru­vi­ca regime against stan­dard-of-care treat­ment: the chemoim­munother­a­py reg­i­men of flu­dara­bine, cy­clophos­phamide and rit­ux­imab (FCR).

Bri­an Koff­man

Da­ta from the tri­al in­volv­ing 529 pre­vi­ous­ly un­treat­ed CLL pa­tients showed that af­ter 3 years, the per­cent­age of pa­tients with pro­gres­sion-free sur­vival was 89.4% in the Im­bru­vi­ca group, ver­sus with 72.9% in the chemoim­munother­a­py arm — meet­ing the main goal of the study. Da­ta on over­all sur­vival al­so fa­vored the Im­bru­vi­ca group at 98.8%, as com­pared with 91.5% in the chemoim­munother­a­py group, over the same time pe­ri­od.

“The gold-stan­dard first-line treat­ment op­tion for many pa­tients with chron­ic lym­pho­cyt­ic leukemia who were fit enough to tol­er­ate an ag­gres­sive treat­ment course had been the in­tra­venous chemoim­munother­a­py of FCR — that is, un­til to­day,” said Bri­an Koff­man, the CMO of the CLL So­ci­ety, in a state­ment.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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Co-CEOs Chintu and Chirag Patel (Amneal)

Look out, Neu­las­ta: A 5th biosim­i­lar is com­ing

As Neulasta sales slip, Amgen has yet another biosimilar to look out for: Amneal Pharmaceuticals and Kashiv Biosciences’ Flynetra.

Flynetra became the fifth approved biosimilar to Neulasta on Friday, snagging a win in neutropenia, a condition common among chemotherapy patients where neutrophils, a type of white blood cell that fights infection, are too low.

As of last summer, the list price of Neulasta was more than $6,400 per dose. It’s designed to be taken in a single dose per chemotherapy cycle. Amneal declined to reveal how much it intends to charge for Flynetra in an email to Endpoints News.