Oncology Insights

News, strategy, and signals in cancer care.

HR-NMIBC mCSPC mCRPC EGFRm NSCLC R/R MM mPDAC

FOLFIRINOX improves PFS vs gemcitabine in locally advanced pancreatic cancer (NEOPAN trial)

May 2025 NEOPAN trial: FOLFIRINOX extends PFS to 12.1 months in LAPC vs 8.5 with gemcitabine.

FDA approves monthly Elrexfio dosing regimen based on long-term MagnetisMM-3 data

FDA approves monthly dosing for Elrexfio (June 2025) in R/R MM based on MagnetisMM-3 data.

NALIRIFOX earns NCCN Category 1 status; real-world and subgroup data support use

NALIRIFOX earns NCCN Category 1 (early 2025); ASCO data highlight subgroup OS of ~19.5 mo.

Talvey + Tecvayli dual bispecific regimen demonstrates high efficacy in R/R

RedirecTT-1 (EHA 2025): Talvey + Tecvayli shows 79% ORR, 54% CR in R/R MM with EMD.

CARVYKTI delivers 5-year remissions; FDA eliminates CAR-T REMS program

CARVYKTI achieves 33% 5-year PFS in CARTITUDE-1; FDA removes REMS for all CAR-Ts (June 2025).

MARIPOSA final OS results establish amivantamab + lazertinib superiority over osimertinib in first-line EGFRm NSCLC

ELCC 2025 MARIPOSA trial: amivantamab + lazertinib shows >12-month OS benefit vs osimertinib in EGFRm NSCLC. U.S./EU approvals followed.

NALIRIFOX (Onivyde Regimen) Achieves 19.5-Month Median OS in Select mPDAC Responders

ASCO GI 2025: NALIRIFOX yields 19.5 month median OS in long-term responders; prognostic markers identified.

Talvey + Tecvayli Dual Bispecific Drives ~79% ORR in Extramedullary R/R MM at EHA

EHA 2025: Talvey + Tecvayli shows 78.9% ORR in extramedullary R/R MM—competitive off-the-shelf alternative to Carvykti.

FLAURA2 Final OS Results Confirm Tagrisso + Chemo as Strong Competitor to RYB+LAZ in EGFRm NSCLC

FDA Eliminates REMS for Carvykti and All BCMA-Directed CAR T in R/R MM

FDA removes REMS for Carvykti and other BCMA CAR T therapies in R/R MM, reducing system barriers and expanding access.

FDA Approves Talazoparib + Xtandi for HRR-mutated mCRPC

FDA approves Talazoparib + Xtandi combo for HRR-mutant mCRPC.

EMA Filing for Akeega in HRR-Mutant mHSPC Based on AMPLITUDE Data

Janssen files Akeega combo for HRR-mutant mHSPC with EMA.

Akeega + AAP Halves Progression Risk in HRR-mutated mCSPC – AMPLITUDE Trial

AMPLITUDE trial: Akeega combo cuts progression by ~50% in HRR-mutant mCSPC.

New DFS Data from SunRISe 1 Cohort 4 for TAR 200 in HR NMIBC

TAR 200 achieves >80% DFS in papillary-only HR NMIBC with low toxicity and high bladder preservation.

FDA Grants Priority Review to TAR 200 NDA in HR NMIBC

FDA fast-tracks TAR 200 for HR NMIBC after strong Phase 2b results showing >80% CR.

Real-world Analysis Supports Early Use of Xtandi in mCSPC

Real-world data support early initiation of Xtandi for improved clinical outcomes in mCSPC.

Nubeqa Shows Favorable Cardiovascular Safety Profile in mCSPC

Darolutamide presents a superior cardiovascular safety profile, beneficial for older mCSPC patients.

Xtandi Exhibits Long-term Survival Benefits in ARCHES and ENZAMET Trials

Xtandi’s robust long-term survival benefit confirmed by ARCHES and ENZAMET trial updates.

Darolutamide Demonstrates Significant HRQoL Benefits in mCSPC Patients

Darolutamide notably delays quality-of-life deterioration and pain progression in mCSPC patients.

FDA Approves Nubeqa (Darolutamide) for Expanded mCSPC Indication

FDA approval broadens Nubeqa's role in mCSPC treatment, significantly impacting therapeutic strategies.

Consistent Safety and Tolerability Profile Confirmed for Erleada

Erleada maintains its proven, predictable safety profile, emphasizing consistent patient care and monitoring.

Long-term Survival Advantage Confirmed in TITAN Phase III Trial

Final TITAN data confirm Erleada’s durable survival benefit in advanced prostate cancer management.

Apa-RP Trial Reports 100% Biochemical Recurrence-Free Survival Post-Prostatectomy

Apa-RP trial highlights Erleada plus ADT’s potential to eliminate recurrence post-prostatectomy.

Erleada Demonstrates 23% Real‑World Overall Survival Benefit Over Enzalutamide in mCSPC

Real-world data confirms Erleada’s significant survival advantage over Xtandi in mCSPC treatment.

Enhanced Risk Stratification through Emerging Biomarkers

Genetic biomarkers advance personalized treatment strategies for NMIBC, improving patient care.

High-intensity Focused Ultrasound (HIFU) Ablation for Bladder Cancer

HIFU offers a promising, minimally invasive alternative for bladder cancer management.

Advances in AI-driven Diagnostic and Prognostic Tools

AI-powered diagnostic tools significantly enhance NMIBC detection, prognosis, and personalized management.

FDA Draft Guidance for Single-arm Trials in BCG-unresponsive NMIBC

New FDA guidance accelerates drug approval processes for urgently needed NMIBC treatments.

Updated EAU and AUA/SUO Guidelines for HR-NMIBC

Updated international guidelines refine and standardize HR-NMIBC patient care and surveillance practices.

Sustained Efficacy of Vicinium (Anti-EpCAM Conjugate)

Vicinium proves its strength with durable efficacy in challenging NMIBC cases.

Development of Intravesical FGFR-targeted Therapies

FGFR-targeted therapies bring precision medicine closer to clinical reality in NMIBC.

TAR-200 Monotherapy Outperforms Combination Therapy in SunRISe-1

TAR-200 monotherapy significantly surpasses combination therapy in efficacy and safety, highlighting its standalone clinical strength.

TAR-200 Demonstrates Strong Efficacy in Papillary-Only Disease (Cohort 4)

TAR-200 shows significant efficacy in papillary-only NMIBC, filling a critical gap in current bladder cancer treatment options.

Positive 12-Month Data and Papillary Cohort Outcomes at AUA 2025

TAR-200 maintains long-term effectiveness at 12 months and demonstrates efficacy in treating papillary-only NMIBC, as highlighted at AUA 2025.

FDA Submission and Priority Review for TAR-200

TAR-200 receives Priority Review from FDA, signaling a rapid pathway toward approval and clinical adoption for bladder cancer treatment.

High Complete Response and Durability in TAR-200 SunRISe-1 Cohort 2

TAR-200 demonstrates exceptional complete response rates and durability as monotherapy in HR-NMIBC patients, with strong safety results presented at ESMO 2024.

Real-world Evidence on Nadofaragene Firadenovec (Adstiladrin)

Adstiladrin demonstrates consistent, robust real-world outcomes for NMIBC.

FDA Approval of ImmunityBio’s Anktiva (N-803 with BCG)

FDA approval of Anktiva offers groundbreaking immunotherapy for challenging NMIBC cases.

Pfizer’s Sasanlimab Combined with BCG Achieves Primary Endpoint

Pfizer's sasanlimab plus BCG significantly improves outcomes in bladder cancer, potentially transforming patient care.