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The FDA did a very unusual thing this week: It included photos from a recent unannounced inspection of an Indian drug manufacturer in its Warning Letter to the company - the first time I believe it's ever done so. Would you believe this is from a drug manufacturer?

Another busy week at FDA!

Lights out, cancer! Pt with advanced ErbB2 exon 20 insertion mutation + lung adenoca progressing with painful bony mets on chemo/immunotherapy switched to the ErbB2 TKI, zongertinib- rapid clinical improvement and essential resolution of PET avid findings on PET/CT shows the switch is now- OFF! 20+ yrs of precision oncology but still just awed each time when the little TKI delivers the TKO! We need to complete proper biomarker testing for each patient to find all these powerful switches! #lcsm

These numbers don’t tell the full story! Great summary by @GIcancerDoc on key real questions in the comments: 1. Is ctDNA ready for all? 2. Can we skip surgery after IO? 3. How much IO is good enough? 4. Role of Chemo here? #OncTwitter #gism @OncUpdates @manjuggm

FDA news media might give a different impression, but Prasad overrode 3 approvals in total, all tied to alignment with the new Covid vaccine framework. 1. **Novavax Nuvaxovid (protein-based COVID-19 vaccine)** – May 2025 Staff recommended full approval for ages 12+. Prasad overruled via memo, restricting it to adults 65+ and high-risk individuals 12–64, citing “diminishing risk” of severe COVID and limited safety data. 2. **Moderna mNexspike (updated mRNA COVID-19 vaccine)** – May 2025 Staff recommended broad approval for ages 12+. Prasad issued an “override memo” restricting it to the same high-risk/elderly groups, citing unresolved myocarditis risks in young males and shifted risk-benefit. 3. **Moderna Spikevax (pediatric/young-children mRNA COVID-19 vaccine)** – July 2025 Staff recommended approval for all children 6 months–11 years. Prasad’s third documented override limited it to children in that age range with underlying risk factors for severe COVID.

@NotGenentech $NVS Piqray now seems like yesterday's tech. Toxic, and hits wild-type. Same for $RHHBY Itovebi (despite the bizarre claim that that's a degrader).

Marty Makary’s job is to tell Pharma no. The media is coming for Marty Makary. Tracy Beth Høeg’s job is to tell Pharma no. The media is coming for Tracy Beth Høeg. The playbook does not change. The strategy works.

Re LUNINOSITY trial: Tough love!

Just in: The phase 3 Talapro-3 trial met its primary endpoint!!! fiercepharma.com/pharma/pfizer-… @OncoAlert @AUC3_Official

Final results of the ATLAS trial are out: KRd > R post-ASCT maintenance in both PFS and OS. Patients with high-risk dz or MRD positivity got 36 cycles of KRd; otherwise, standard risk + MRD negative (after 6 cycles) got only 8 cycles of KRd before de-escalation to R. The obvious caveats are this was done pre-anti-CD38 era and most received thalidomide (vs len) during induction. We did not see profound differences in dropout by study arm. We do see that more is...more in this setting. And that MRD-guided de-escalation works for standard-risk!

Another negative anti-TIGIT trial Even in one of the most immunogenic cancers, TIGIT + PD1 failed again in phase 3 in the adjuvant setting. This strategy may be dead thelancet.com/journals/lanon…

Frontline CAR-T for newly diagnosed multiple myeloma? A phase II trial explored BCMA CAR-T therapy as frontline treatment for patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for or not proceeding to transplant. 🧪 Study design: • Induction (3–4 cycles) → BCMA CAR-T infusion → consolidation + lenalidomide maintenance • 36 patients infused • Median age: 68 years 📊 Striking results: • MRD negativity: 100% at 3 months (10⁻⁵ sensitivity) • No MRD recurrence at median follow-up of 15.8 months • CR rate improved from 33% pre-infusion → 69% at 3 months → 94% at last follow-up ⚠️ Safety profile: • Cytopenias common but transient • Cytokine release syndrome: 52.8% (all grade 1–2) • Neurotoxicity: 5.6% (all grade 1) • No deaths or disease progression at data cutoff 💡 Why it matters: Patients who cannot undergo transplant often have fewer therapeutic opportunities. Early CAR-T may offer deep, durable remissions in the frontline setting. 🚀 Takeaway: Frontline BCMA CAR-T could represent a practice-changing strategy for transplant-ineligible NDMM—pending larger confirmatory trials. ascopubs.org/doi/10.1200/JC… #MultipleMyeloma #CARTcells #BCMA #Hematology #CancerImmunotherapy #ClinicalTrials #MRD

When FDA, NIH, & CMS work closely together, good things happen. Amazing morning at CMS’s 2026 Quality Conference!

The intuition makes sense. Reduce tumor burden, let systemic therapy finish the job. But intuition has a poor track record in oncology. ORCHESTRA just published in JAMA. Phase 3 RCT, 382 patients, multiorgan mCRC. The bar for entry was high. You had to be able to take out more than 80% of disease burden across all sites before randomization. These are the best-case patients. Response or stable disease after 3-4 cycles of CAPOX or FOLFOX, then chemotherapy alone versus chemo plus debulking. Median OS: 27.5 months versus 30.0 months. HR 0.88, 95% CI 0.70-1.10. p = 0.26. PFS essentially identical, 10.4 versus 10.5 months. Serious adverse events significantly higher in the debulking arm, 53% versus 39%. That said, this isn’t the whole story. Symptomatic Krukenberg tumors, oligometastatic disease with curative intent, isolated liver-only disease. Those conversations should still be had. The cytoreductive surgery literature gave us hints this was coming, but the use cases that make biological sense still stand. What changes now? At minimum, “we can get more than 80% of it” is not a sufficient reason on its own. Except in NETs, NETs are weird. jamanetwork.com/journals/jama/… @gutonclab @oncoalert

FDA is expanding its use of real world evidence.

I have been diagnosed with MM - what's next? A brief primer for patients tribunecontentagency.com/article/unders…

Not personal but I’m not sure of the wisdom of having guideline authors write editorials on their own guideline 👇🏻👇🏻

In 2026 there is NO role for bortezomib/carfilzomib maintenance for patients with multiple myeloma.

Congrats @UroDocAsh on receiving the Platinum Award 2026 @EUplatinum @EurUrolOncol for your leadership & being a source of inspiration! @Albert0Briganti @montypal @carme_mir1

Great news on biosimilars. Decades in, are we finally allowed to say in polite society they’re basically the biologic version of generics? Iykyk.