We need an Innovation Review Voucher, where a USA innovator (not others) can apply, based on their innovation in a drug category or molecule, for super fast regulatory approval, AND a transferable and subdividable 3 year commercial exclusivity, which covers the structure and close derivatives.
Applications would be 90 day decisions, with a standard that a reasonable person would conclude that the technology was used or copied by the entity. In practice, this should prevent USA innovation from being decimated via less funding flowing in (which hurts patients in the long run), and if the commercial delay is critically important the vouchers are tradeable, and can be granted to more than one party at the discretion of the holder, so patients are protected.
Prob have like ARPA H like structure or some new DOC panel to do it.
Great slide (Bluestar Advisors) about progress across different cancers.
They looked at OS improvement in 1st line patients and divided indications to blue ocean or red ocean based on magnitude of improvement.
Biggest progress was in melanoma and renal cancer (PD1/CTLA4), HRD-ovarian cancer (PARP) and breast cancer (CDK4, HER2).
Good news is a lot of the blue ocean indications at the bottom will see new effective therapies that should translate to a meaningful benefit when they reach 1st line:
💢Head and neck - EGFR bispecifics (peto, amivantamab)
💢Small cell lung cancer - DLL3 T cell engagers and Topo1 ADCS (DLL3, SEZ6, B7H3)
💢Ovarian/ endometrial - Topo1 ADCs (FRa, CDH6, NaPi2b)
💢Pancreatic - RAS inhibitors
GBM, colorectal and liver still look very challenging...
“Doctor, what is the right therapy for me?”. Lately, the answer to this Qx has become increasingly unclear among pts with ER+ MBC. We have CDKs, SERDs, PI3K-Akt-mTOR agents, ADCs, chemo— & insufficient biomarkers. Thanks @OncNewsCentral for the interview. https://t.co/6xcDYC5xjN
A standing ovation moment at #ESMO25
In front of more than 9,000 cancer specialists and researchers, the Phase 3 RC48-C016 trial redefined the outlook for HER2-expressing urothelial cancer:
Disitamab vedotin + Toripalimab nearly doubled overall survival over chemotherapy — marking the arrival of the ADC + IO era in this disease.
#UrothelialCancer #Oncology #DisitamabVedotin #Toripalimab #Immunotherapy #ADC #IOcombination
@myESMO@OncLive@CParkMD@tugbawitter@Dr_ElvinaA @atakansare2016 @drmukremin@dr_yakupergun@OncoAlert@alimurattat@DrYukselUrun
in 2L HER2+ metastatic breast cancer, in 10 years, from 2012 to 2022, we have reduced risk of progression and death by !!80%!!
- Lapatinib + cape 6.4 months
- TDM1 9.6 months
- TDXd 29.1 months
#ESMO25 Dr. Rupert Bartsch
🚨 Cancer of unknown primary (CUP) has long been a therapeutic challenge with poor outcomes.
New data show that molecularly guided therapy and immunotherapy can improve survival, while ctDNA, methylation profiling, and AI-based pathology enable precision strategies.
📖 @NatRevClinOncol
DOI 👉 https://t.co/JelxgNVLUk
#CánCare #oncology #CUP #precisiononcology
T-DXd is approved for the treatment of patients with ANY treatment-refractory HER2+ (IHC 3+) tumor, making of it the first agnostic ADC. Unlikely to be the last. Key priority: ensuring that HER2 testing is expanded across cancer types. Exciting times! https://t.co/QKQqtJ7d5H
After a standing ovation at #ESMO23, the EV-302 phase 3 trial of EV/pembro (vs platinum/gem) in 1L mUC by @tompowles1 et al is published on @NEJM. OS nearly doubled with the ADC/IO combo. Targeted chemo delivery keeps reshaping practice across tumor types. https://t.co/fpUIgze5mG
$PFE $MRK $SGEN Padcev + Keytruda in 1L urothelial EV-302, via Thomas Powles. Survival benefit irrespective of cisplatin eligibility or PD-L1 status. New SoC #ESMO23 $BCYC
🟢DESTINY-Breast04: standing ovation more than deserved👏. T-Dxd showed to improve PFS and OS in pretreated HER2-low (1+ and 2+ ISH -) #MBC patients vs TPC. "The ADC era has just begun also in HER2-low BC". These results speak for themselves. @CamillaLisanti#ASCO22#BCAreporter
$AZN $MRK Lynparza in 1L Maintenance BRCAm ovarian cancer data out in NEJM --> $CLVS $TSRO
https://t.co/g93Ty2wYHb
PFS HR=0.30
One of the most amazing PFS curve this year!
Who designs better synthetic routes -- humans or computers? #Chemists test out computer-programmed #syntheses for the first time:
https://t.co/Ar6fBn7k7j
Prediction of protein structure directly from DNA sequence is a holy grail of biology. Exciting new work from @MoAlQuraishi:
https://t.co/L5n2NrefG3
Different from other approaches (e.g., coevolution, simulations). Could maybe be combined with them for even greater accuracy.