FDA hands As­traZeneca and Mer­ck a snap OK to mar­ket Lyn­parza in front­line ovar­i­an can­cer, mark­ing a new stan­dard in treat­ment

As­traZeneca just showed how fast an es­tab­lished can­cer drug can achieve a cru­cial line ex­ten­sion.

Just two months af­ter the phar­ma gi­ant and its part­ners at Mer­ck turned up at ES­MO to tout some tru­ly im­pres­sive de­tailed re­sults for Lyn­parza as a front­line ther­a­py for BR­CA-mu­tat­ed ovar­i­an can­cer, the agency has come through with a snap OK.

The key da­ta point: A haz­ard ra­tio of 0.30, with a pro­found 70% re­duc­tion in risk of death. These days, the FDA is not re­luc­tant to slap an OK on a can­cer drug, and As­traZeneca’s R&D team has spent years work­ing on an ex­pand­ed mar­ket for the drug af­ter win­ning the pi­o­neer­ing ap­proval for a PARP in­hibitor.

GSK’s re­cent ar­rival on the scene with a buy­out for a now shrunk­en PARP ri­val has un­der­scored the lead that As­traZeneca and Mer­ck have built up here. And shares of Clo­vis de­clined 6% af­ter the news, which fur­ther over­shad­owed its PARP Rubra­ca.

In the SO­LO-1 study 60% of the women re­ceiv­ing the drug were pro­gres­sion-free at 3 years, com­pared to less than half that in the place­bo group.

Kath­leen Moore

As­traZeneca’s suc­cess with Lyn­parza and Tagris­so, with ear­ly in­roads in­volv­ing Imfinzi, have helped pave a long-await­ed turn­around for the com­pa­ny, which has suf­fered through a dra­mat­ic on­slaught of gener­ic com­pe­ti­tion as their fran­chise drugs lost patent pro­tec­tion. And the FDA, which has sig­naled its readi­ness to speed up the game of R&D, has wast­ed no time in help­ing them swift­ly ad­vance.

“SO­LO-1 is tru­ly a land­mark tri­al in gy­ne­co­log­ic can­cer.” said Kath­leen Moore, the co-prin­ci­pal in­ves­ti­ga­tor.”This ap­proval will like­ly change the way we treat women with BR­CA-mu­tat­ed ad­vanced ovar­i­an can­cer. The abil­i­ty to of­fer this im­por­tant first-line main­te­nance treat­ment op­tion to el­i­gi­ble pa­tients may slow down or even stop the nat­ur­al course of dis­ease pro­gres­sion.”

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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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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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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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.

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.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.