Practice-Changing FDA Approvals
The oncology approvals reshaping practice — with the KOL reaction that matters. Every quote is verbatim from a verified oncologist and links to the original post.
Subcutaneous Isatuximab — Sarclisa Escena
First anti-CD38 antibody delivered by an on-body injector — approved across all Sarclisa myeloma regimens (Isa-VRd, Isa-Pd, Isa-Kd). Infusion reactions fell from 25% (IV) to 1.5%. Sanofi.
IRAKLIA study shows on body delivery system is safe, effective and preferred by patients. Cool fearture that time of administration depends on tissue resistance. Called "escargot" in France! Less infusion/injection reactions (1.5 vs 25%) #ASCO25
Phase 3 IRAKLIA study shows Isatuximab (+Pom/dex) w/ on-body delivery system shows similar efficacy & pharmacokinetic non-inferiority versus Isa-iv/Pom/dex w/ no unexpected safety signal and lower infusion reaction rate
Enfortumab Vedotin + Pembrolizumab — Padcev + Keytruda
Perioperative muscle-invasive bladder cancer — label expanded to cisplatin-ELIGIBLE patients undergoing radical cystectomy. First platinum-free perioperative regimen to beat chemo in ~25 years. Astellas/Pfizer + Merck.
Now, the combo of EV-Pembro is @US_FDA approved for all muscle-invasive bladder cancer
KEYNOTE-B15/EV-304 trial is practice-changing: periop EV+ pem: 47% reduction in risk of events (HR 0.53), Significant OS benefit (HR 0.65), pCR 55.8% vs 32.5%. A true paradigm shift for cisplatin-eligible MIBC. Honored to be part of this milestone with our HCSC team
Sacituzumab Govitecan ± Pembrolizumab — Trodelvy
Two first-line metastatic TNBC approvals — Trodelvy monotherapy for PD-L1-negative / IO-ineligible disease (ASCENT-03) and Trodelvy + Keytruda for PD-L1-positive CPS≥10 disease (ASCENT-04). Gilead + Merck.
A lot is happening in breast cancer! ASCENT-04 reports improvement in PFS for sacituzumab + pembro vs TPC+pembro in 1L mTNBC, & DESTINY-Breast09 reports improved PFS for TDXd+P vs THP in 1L metastatic HER2+ breast cancer! Nice to see new options for our pts!
First-line Sacituzumab + Pembrolizumab improves PFS in 1st Line TNBC. Crossover 80% Sacituzumab Offered! Very few patients with prior IO, few who relapsed within 6-12 months. OS looks similar but early days.
Palbociclib Maintenance — Ibrance
Added to trastuzumab ± pertuzumab + endocrine therapy as first-line MAINTENANCE for HR+/HER2+ metastatic breast cancer. Median PFS 44.3 vs 29.1 mo (HR 0.74). Pfizer / Alliance Foundation Trials.
Otto Metzger (@Otto_DFCI) presents the practice-changing results from the #PATINA phase 3 trial: adding palbociclib to maintenance ET after 1L THP for HR+/HER2+ MBC significantly and meaningfully improved PFS (44 vs 29 months, HR 0.74, p=0.007).
T-DXd + pertuzumab approved for 1st L HER-2+ #bcsm! Now for the debates around induction length, maintenance, re-induction etc. My opinion: I'll induce to maximal patient response (this will likely be longer than 6 cycles), then move to maintenance with PATINA or HER2CLIMB05.
Capivasertib + Abiraterone — Truqap
PTEN-deficient metastatic hormone-sensitive prostate cancer, with the VENTANA PTEN companion diagnostic co-approved. rPFS 33.2 vs 25.7 mo (HR 0.81); overall survival immature at approval. AstraZeneca.
Breaking new: today @US_FDA approved capivasertib (oral AKT inhibitor) for the metastatic HSPC/APMS #prostatecancer with PTEN deficiency — personalized medicine continues to leap forward
FDA approved capivasertib + abiraterone/prednisone for PTEN-deficient metastatic prostate cancer. Grateful to have been one of the investigators in CAPItello-281.
Teclistamab + SC Daratumumab — Tec-Dara
Relapsed/refractory multiple myeloma after ≥1 prior line (PI + IMiD). First Phase 3 of a BCMA×CD3 bispecific combination — PFS HR 0.17; 36-month OS 83.3% vs 65.0%. Johnson & Johnson.
This is the one of the most incredible outcome difference I have seen in myeloma: Results of the randomized Majestec-3 trial in myeloma. @mvmateos HR 0.17 !! Late breaker at #ASH25
Implications are many: Off-the-shelf, highly active, outpatient-based, community-accessible, T-cell redirecting therapy. Steroid free with a convenient schedule. It will force us to reappraise options in 1-3 LOT.
