Physician Sentiment on KISQALI®

Q: What do oncologists think of the NATALEE trial (KISQALI®)?

Across 57 verified physician voices in KOL Pulse's index for NATALEE, 20% expressed positive sentiment, 19% were nuanced (praising the result while flagging a caveat), 42% were neutral, and 19% were critical. Positive voices highlight the invasive-disease-free-survival benefit of adding ribociclib to adjuvant endocrine therapy, extending CDK4/6 inhibition into the curative early-breast-cancer setting including node-negative disease; nuanced and critical voices flag the three-year treatment duration and tolerability/discontinuation, overall-survival maturity, and patient selection versus abemaciclib's monarchE (node-positive) population.

Q: Where can I find the NATALEE trial data for KISQALI® (ribociclib)?

NATALEE is registered as NCT03701334 and studied KISQALI® (ribociclib) in Adjuvant HR+/HER2- stage II/III early breast cancer at high risk of recurrence (ribociclib + aromatase inhibitor). For the full NATALEE trial data and conference coverage, see the KOL Pulse NATALEE trial profile at kolpulse.com/kol-pulse-trial-profile-natalee.

Q: Is KISQALI® (ribociclib) FDA approved?

KISQALI® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated 2026-07-13. KOL Pulse reports the physician conversation and does not endorse any product.

Trial 1 · NCT03701334

What do oncologists think of the NATALEE trial (KISQALI®)?

NATALEE — Adjuvant HR+/HER2- stage II/III early breast cancer at high risk of recurrence (ribociclib + aromatase inhibitor)

FDA APPROVED · Sep 2024FDA-approved September 17, 2024, with an aromatase inhibitor for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence.

Physicians are broadly favorable, with real nuance on NATALEE: 20% of 57 verified physician voices positive, 19% nuanced (praising the result while flagging a caveat), 42% neutral, 19% critical.

20%

19%

42%

19%

Positive 20% Nuanced 19% Neutral 42% Critical 19%

Denominator: 57 distinct verified physician voices across 143 oncologist posts, 2023-03-27 to 2026-05-31. Sponsor: Novartis

See full NATALEE conference coverage & trial data →

Primary sources: ClinicalTrials.gov · NCT03701334 · FDA — NATALEE adjuvant approval (Sep 2024)

FDA approval (Sep 17, 2024): ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence (based on NATALEE, NCT03701334).

Physician voices — verbatim

Representative positive voice

🔥 HUGE news in breast oncology. The #NATALEE phase 3 trial of adjuvant ribociclib for stage II-III breast cancer met the primary endpoint of iDFS! https://t.co/9iCgp5MCaf

Paolo Tarantino

@PTarantinoMD

Representative nuanced voice

NATALEE phase 3 trial... deserves a sensitivity analyis ! remember the monarchE trial (adjuvant abemaciclib for 2⃣ years) --> now we have NATALEE with adjuvant ribociclib for 3⃣ years ‼️ iDFS benefit ! ... but let's have a closer look ! 1/🧵 https://t.co/gxslqkfCF9

Timothée Olivier, MD

@Timothee_MD

Representative critical voice

NATALEE: A good example of clinically insignificant ~3% benefit in a contrived endpoint at 3-years that jacks up toxicity, plus what happens at ~40 months? Hard to tell without CIs https://t.co/eo4krzODl2

M. Bolton

@5_utr

Full physician voice list (57)

Physician	Comment (verbatim)	Sentiment	Impressions
Yakup Ergün @dr_yakupergun	Ribociclib plus Endocrine Therapy in Early Breast Cancer : NATALEE 3y-iDFS: 90.4% vs 87.1% (HR:0.75) https://t.co/tdzIF8ctHs	Neutral	57,615
Vinay Prasad MD MPH @VPrasadMDMPH	If you can fit a laser pointer between the curves, you can give the #ASCO24 plenary!	Neutral	53,932
Paolo Tarantino @PTarantinoMD	🔥 HUGE news in breast oncology. The #NATALEE phase 3 trial of adjuvant ribociclib for stage II-III breast cancer met the primary endpoint of iDFS! https://t.co/9iCgp5MCaf	Positive	49,807
Sara Tolaney @stolaney1	NATALEE: Adj ribociclib for ER+ BC iDFS now with 33 mo of f/u 43% completed 3 yrs of ribo 35.5% with early discontinuation 20.7% still on ribociclib Improvement in iDFS: 90.7vs 87.6% HR 0.749, p=0.0006 @OncoAlert #SABCS23	Neutral	28,984
Timothée Olivier, MD @Timothee_MD	NATALEE phase 3 trial... deserves a sensitivity analyis ! remember the monarchE trial (adjuvant abemaciclib for 2⃣ years) --> now we have NATALEE with adjuvant ribociclib for 3⃣ years ‼️ iDFS benefit ! ... but let's have a closer look ! …	Nuanced	24,458
Harold J. Burstein, MD, PhD, FASCO @DrHBurstein	Important data from monarchE and NATALEE adjuvant CDK46 inhibitor @myESMO With @tess_omeara, here's our take on who needs, and who does not need, adjuvant abema/ribo, co-published in @Annals_Oncology	Neutral	23,720
M. Bolton @5_utr	NATALEE: A good example of clinically insignificant ~3% benefit in a contrived endpoint at 3-years that jacks up toxicity, plus what happens at ~40 months? Hard to tell without CIs https://t.co/eo4krzODl2	Negative	15,104
Elisa Agostinetto @ElisaAgostinett	Adjuvant CDK4/6i for early #breastcancer: how to choose wisely⁉️ In this work we discuss the most recent findings from #MonarchE and #NataLEE trials and put them in perspective for potential use in clinical practice @Lucarecco @E_de_Azambu…	Neutral	14,146
Stephanie Graff, MD, FACP, FASCO @DrSGraff	Considering Adjuvant CDK4/6 Inhibitors?: monarchE and NATALEE in Clinical Practice https://t.co/ZKomXSH3gx #bcsm @ASCO	Neutral	13,632
Oncology Brothers @OncBrothers	#Ribociclib now @US_FDA ✅ for adj early stage HR+ breast cancer. Recent #ESMO24 #NATALEE: Stg IIA - III, 400mg (3wks on/1wk off) for 3yrs - Improved iDFS w/Ribo at 4yrs (HR: 0.715) - Improvement seen in all subgroups including N0. OS immat…	Nuanced	12,620
Hope Rugo @hoperugo	#ESMO25 beautiful discussion by @AngieDemichele covering monarchE and Natalie. Key points below.	Positive	8,191
Ilana Schlam @IlanaSchlam	iDFS NATALEE 3-year iDFS 88% vs 91% favoring ribo Similar benefit in stage 2 and 3, but greater in 3 Node negative group, similar % but not statistical sig (small n) DDFS 91% vs 93% favoring ribo OS data not mature @SABCS23 @oncoalert #b…	Nuanced	5,873
Dr Amol Akhade @SuyogCancer	More I See these curves of Natalee trial , more I feel , this is NOT the one . IDFS curves are actually crossing each other at 40 weeks . HR for almost all subgroups touching or crossing unity . Only 20 % completed 3 years of ribociclib.…	Negative	4,586
Luca Arecco, MD @Lucarecco	Out on @Oncology_Ther our commentary on the main analogies and differences between #MonarchE and #NataLEE trials and perspective on CDK4/6i use in the adjuvant setting of #high-risk HR+ pts. @ElisaAgostinett @E_de_Azambuja @OncoAlert @UniG…	Neutral	4,583
Dr Rishabh Jain @DrRishabhOnco	#ASCO26 🧬 Not all HR+/HER2- early breast cancers behave the same. New biomarker analysis from NATALEE suggests adjuvant ribociclib benefits were seen across ALL PAM50 subtypes, with a possible trend toward greater benefit in genomically hi…	Neutral	4,403
Elisabetta Bonzano MD, PhD @to_be_elizabeth	📌Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in younger patients (pts) with HR+/HER2-early breast cancer (EBC) in NATALEE @OncoAlert #OncoAlertAF @LoiSher #ESMO24	Neutral	3,067
Dra. María Natalia Gandur Quiroga @nataliagandur	💫🌟🚨 Top 10 #BreastCancer abstracts for #ASCO26 — selected by our leads and finalized via a Delphi voting process 🗳️🔬 1️⃣ 500 — OPTIMA 2️⃣ LBA1006 — PERSEVERA BC 3️⃣ 507 — KEYNOTE-522 final analysis 4️⃣ LBA1007 — SERENA-6 5️⃣ 502 — LIDERA B…	Neutral	2,803
Matteo Lambertini, MD PhD @matteolambe	Presented by super @LoiSher at #ESMO24 data from the #NATALEE trial on the benefit of adding #ribociclib to adjuvant endocrine therapy according to age…follow-up still short but signal of larger benefit in young women #ESMOAmbassadors @myE…	Nuanced	2,724
Jame Abraham, MD, FACP @jamecancerdoc	One more treatment option for #breastcancer patients with ER + her-2 negative, early stage breast cancer - https://t.co/YyF3ljvuVW	Neutral	2,624
Mitsuo Terada, MD, PhD@乳腺科医 @MamMa_mimumemo	NATALEE試験において、結局、アジュバントでのRibociclibはPAM50によるサブタイプに関わらず上乗せ効果あり。誰にでも同じぐらい効いていたとも言えるけど、いまいちいいバイオマーカーが出てこないからやらなくていい集団がいまいち見つからないCDK4/6阻害薬… #ASCO26	Neutral	2,462
Jason A. Mouabbi MD @JAMouabbi	The updated #NATALEE trial results are here. The benefit still maintained with patients receiving #ribociclib having 25% reduced risk of recurrence with 78% not on therapy at the time of data cut off! Kudos to “El Jefe” Dr. Gabriel Hortoba…	Positive	2,390
Eleonora Teplinsky, MD @drteplinsky	Super important work given what was presented with updated IDFS data with NATALEE! Congrats! 👏 #ESMO24	Positive	1,846
Guilherme Nader Marta @GuiNaderMarta	#NATALEE trial results now published in the @NEJM The addition of adjuvant ribociclib (for 3 years) to an aromatase inhibitor improved iDFS by 3.3% at 3y (HR 0.75) in patients with stage II-III ER+ BC https://t.co/GpShwKh7YQ @OncoAlert	Neutral	1,724
Aditya Bardia, MD @dradityabardia	Positive results from Natalee trial evaluating ribociclib, CDK 4/6i with ET vs ET as adjuvant therapy for early HR+ breast cancer. Different from MONARCH-E/abemaciclib: 3 year ribo duration & inclusion of stage II-III disease. #bcsm ⁦@TRIOn…	Positive	1,545
Kazuki Nozawa, MD @kazuki_nozawa	NATALEE Biomarker Analysis #ASCO26 Ribociclib + NSAI demonstrated consistent iDFS benefit across all PAM50 intrinsic subtypes in HR+/HER2− early breast cancer — regardless of luminal A, luminal B, HER2-enriched, or basal-like classificat…	Neutral	1,357
Erman Akkus @Erman_Akkus	📣 Adjuvant ribociclib + AI vs AI Stage II-III hormon positive breast ca NATALEE @NEJM ✅Invasive disease free survival at 3 yr : 90.4% vs 87.1%, HR: 0.75 (0.62-0.91), p= 0.003 👉https://t.co/EIdkXJtt4O -------------------------------- @A…	Positive	1,249
Ahmed Alanazi \| أحمد العنزي @alanazi002	#NATALEE trial age < or > 40 years old differ? #efficacy vs #Safety Safety profile? AE lead to discontinuation doubled in age >40 yo specially transaminases? @myESMO @OncoAlert #ESMO24	Positive	1,191
Gianmarco Ricagno, MD @giammi107	Can we agree that clinical benefit is marginal and probably due to huge sample size?	Neutral	1,056
Erika Hamilton, MD, FASCO @erikahamilton9	Benefit of #ribociclib in #NATALEE: - persists across intrinsic subtypes - is greater in pts with higher risk tumors - may be variable based on certain gene expression ( ⬆️ benefit CEACAM6, ⬇️ CDK4, GATA3 etc) #ASCO26 #bcsm	Neutral	1,026
Jeff Sharman @jeff_sharman	Anybody try to calculate a "number needed to treat" on that one? If you need 5K patients to have statistical difference, it tells you it is small. Unless the curves continue to separate - the value is....	Negative	998
Eric Widera, MD @EWidera	They need to take a note from the amyloid antibody for Alzhiemers studies: zoom in on the y axis and change the starting point to magnify differences. Like magic, now you got a graph that you can talk about...	Negative	973
Steven Vogl @VoglNY	IDFS is a dumb endpoint for adjuvant trials. DDFS is a preliminary surrogate and OS is the only correct and definitive endpoint. If no OS advantage, then showing a lifetime QOL benefit would be of interest, but very hard to define and compa…	Nuanced	919
Ibrahim Azar, MD @ibrahimazaronc	The curves really look inseparable. And you're increasing toxicity significantly for a very tiny increase in DFS. If the IDEA trial was interpreted similar to this, we'd give everyone 6m capeox. I'm also surprised it made it to NEJM as abe…	Negative	865
David McCune @davidemccune	Was 36 month DFS the prespecified endpoint? Because that looks like literally the only month where there was a benefit.	Negative	768
Stanislav (Stas) Lazarev, MD @StasLazarev	is losing credibility by publishing studies like this. INDIGO trial, last week's CAR-T for recurrent glioblastoma, now this study - none of these interventions benefit pts in any meaningful way, but guarantee revenue increase for pharmaceut…	Nuanced	688
Evandro de Azambuja, MD, PhD @E_de_Azambuja	presents data on young patients treated with #ribociclib in Natalee #ESMO24 #ESMOAmbassadors	Neutral	679
tatsunori_shimoi 下井辰徳 @shimoi_oncology	リボシクリプの術後内分泌療法への追加を見たNATALEE試験のバイオマーカー別サブ解析内因性サブタイプがluminalより他のタイプの方が差が大きく見えたり、アグレッシブな遺伝子変化のほうが大きな利益は興味深いアベマシクリブも似た話になりそう #ASCO26	Neutral	559
Gaia Griguolo @GaiaGriguolo	NATALEE gene-expression analysis presented #asco26 Ribociclib benefit seen across all PAM50 intrinsic subtypes Trend toward greater benefit for higher genomic risk or proliferation signatures Expression of several gene associated with in…	Neutral	547
Ramez Kouzy, MD @RKouzyMD		Neutral	487
Heather McArthur, MD, MPH @hmcarthur	BTW, its coke all the way!! :)	Positive	467
Icro Meattini @Icro_Meattini	Prognostic and predictive impact of baseline gene expression in the NATALEE trial of adjuvant ribociclib + nonsteroidal aromatase inhibitor in HR+/HER2− early #BreastCancer Stephen K.L. Chia #ASCO26 @OncoAlert #OncoAlert	Neutral	448
Martin Schoen MD MPH @mwschoen	Also can guarantee there will be differential censoring that affects the treatment arm. The less fit patients on ribociclib will have adverse events and therefore the populations end up being different over a several year period. Might make…	Nuanced	407
Ana Go @GoAnaGo	Final iDFS analysis of NATALEE trial. Ribociclib 400 mg x3 yrs in adjuvant BC treat, maintain significant benefit but 1.6% over NSAI alone for stage II vs. 4.3% in stage III. Differences with not statistically significant for node-negative …	Nuanced	402
Preet Paul Singh, MD @PreetpaulS	Sorry. That doesn’t look practice changing at all. Those curves are literally overlapping. Giving a toxic and expensive drug for 3 years for that “benefit” seems egregious. First do no harm.	Positive	323
Aya Mohamed \| MSc, MD 🎗 @dr_oncologista	NATALEE Trial: Consistent iDFS Benefit with Ribociclib Across All PAM50 Intrinsic Subtypes in HR+/HER2− Early #BreastCancer @OncoAlert @ASCO #ASCO26 #bcsm	Neutral	321
Muhammad Ali Rizvi, MD. @ariznova	Natalee Trial : significant drop out due to toxicity . Might benefit from streamlining the patient population . #sabcs	Neutral	233
Santhosh Ambika @RenoHemonc	Obscenely skewed cost benefit ratio ..	Negative	226
Michiel Strijbos @StrijbosMichiel	Let's do more ridiculously overpowered trials....	Negative	188
Daniel Koffler, MD @dmkoffler	I could not in good conscience recommend an intervention with such a questionable benefit at the cost of massively higher hematologic toxicity	Negative	183
Mali Barbi, MD MSc \| Gyn & Breast Onc @DrBarbiOnc	Great summary. The NATALEE update is the real needle-mover here—seeing that 8.9% delta in Stage IIIB/C makes the Ribo + NSAI discussion much easier in the clinic. > However, the ALTTO 10-year data is a great reminder that while DFS is impro…	Nuanced	123
Andres Ossa @tumastologo1	I believe that the benefit in premenopausal women is very short given the economic toxicity and side effects in these patients that would limit its use. #ESMO24 #natalee	Negative	111
Nagi El Saghir MD, FASCO, FACP @NagiSaghir	Interesting! We observed similar more benefits in patients <40 with Ribociclib + ET in RIGHT Choice trial!	Positive	108
Bijoy Telivala @BijoyTelivala	Never understood why we created and allowed endpoints like PFS/IDFS etc Why not use good end points like OS and QoL These surrogate endpoints dont help many pts but helps pharma and wall street	Nuanced	81
Hakan Önder @onder_haka2124	Is your paradigm really going to change with the censored patient numbers at 36 months in NATALEEA? The percentage of patients who continued on treatment at 36 months was 8%. What do you think about the other adjuvant study, MonarchE? Highe…	Nuanced	79
thomas tucker @tommytuckermd	Call me when there's an OS benefit	Negative	51
drcammclaren @drcammclaren	I have never had a patient sit in front of me and ask for a better IDFS. OS and QOL all the way. If the HR of PFS or IDFS is so great that an OS benefit is likely, it "may" suffice until the actual OS data is out.	Neutral	47
Tõnis Metsaots @TMetsaots	US prices are crazy. in EU CDK4/6 inhibitors cost a fraction of that. Don't know how extensively have you used ribo, but usually it's well tolerated, since most AE-s are asymptomatic. HR pos mBC median OS is 64m, so demanding OS benefit …	Positive	28

See full NATALEE conference coverage & trial data →

Regulatory

KISQALI® — FDA status

FDA APPROVEDKISQALI® (ribociclib) is FDA-approved for HR-positive, HER2-negative breast cancer — both advanced/metastatic disease and, since September 2024, the adjuvant treatment of high-risk stage II/III early breast cancer (with an aromatase inhibitor). For the full, current list of FDA indications and prescribing information, see kisqali.com or FDA label (DailyMed). KOL Pulse indexes the physician conversation; the label is owned and maintained by the manufacturer.

Frequently Asked

KISQALI® sentiment — FAQ

NATALEE

What do oncologists think of the NATALEE trial (KISQALI®)?

Across 57 verified physician voices in KOL Pulse's index for NATALEE, 20% expressed positive sentiment, 19% were nuanced (praising the result while flagging a caveat), 42% were neutral, and 19% were critical. Positive voices highlight the invasive-disease-free-survival benefit of adding ribociclib to adjuvant endocrine therapy, extending CDK4/6 inhibition into the curative early-breast-cancer setting including node-negative disease; nuanced and critical voices flag the three-year treatment duration and tolerability/discontinuation, overall-survival maturity, and patient selection versus abemaciclib's monarchE (node-positive) population.

Where can I find the NATALEE trial data for KISQALI® (ribociclib)?

NATALEE is registered as NCT03701334 and studied KISQALI® (ribociclib) in Adjuvant HR+/HER2- stage II/III early breast cancer at high risk of recurrence (ribociclib + aromatase inhibitor). For the full NATALEE trial data and conference coverage, see the KOL Pulse NATALEE trial profile at kolpulse.com/kol-pulse-trial-profile-natalee.

Regulatory

Is KISQALI® (ribociclib) FDA approved?

KISQALI® is FDA-approved. KOL Pulse organizes this page by clinical trial and links out to the manufacturer's brand site and the FDA label for the full, current list of FDA indications and prescribing information — the label is owned and updated by the manufacturer, so we point to it rather than reproducing it.

Methodology

How this index is built

KOL Pulse indexes verbatim posts from verified oncology physicians and rolls sentiment up per clinical trial. Each physician is counted once per trial, at their highest-reach post. Sentiment is classified from the verbatim text (positive / nuanced / neutral / critical), where "nuanced" marks a voice that praises the result while flagging a substantive caveat (immature overall survival, toxicity, or trial-design/selection concerns). Institutional, media, finance, and non-physician accounts are excluded from the denominator. Quotes are reproduced verbatim and attributed to the physician's public post. KOL Pulse organizes this page by clinical trial — the maintainable unit — and links out to the manufacturer's brand site and the FDA label for the full indication list, which the manufacturer owns and updates. Trial efficacy figures are held for medical-expert verification before publication. This page reports the physician conversation; it is not medical advice and does not endorse any product.