📢 The Latest Phase 3 Data! 🚀 Natera announced publication of Phase III CALGB (Alliance)/SWOG 80702 data in JAMA Oncology, showing Signatera™ can identify colorectal cancer (CRC) patients most likely to benefit from celecoxib plus chemotherapy.

🚨 The Latest FDA Approval Alert! ✅ The FDA approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro®, Janssen Biotech, Inc.) for subcutaneous injection across all indications previously approved for the intravenous formulation of amivantamab. 💉This approval introduces a SC formulation option.

🚨 The Latest FDA Approval Alert! ✅ Rucaparib (Rubraca®) approved for adults with BRCA-mutated metastatic castration-resistant prostate cancer previously treated with an AR-directed therapy. 🔬 Patients should be selected using an FDA-approved companion diagnostic.

🚨 The Latest Approval Alert! ✅ Incyte announced European Commission approval of Minjuvi® (tafasitamab) for adults with relapsed or refractory follicular lymphoma. 🔹Minjuvi® (tafasitamab) + lenalidomide + rituximab becomes the first CD19/CD20 dual-targeted immunotherapy regimen approved in Europe.

📢 The Latest Phase 3 Data! 🚀 PADCEV® (enfortumab vedotin) + Keytruda® (pembrolizumab) becomes the first and only platinum-free regimen to improve survival when used perioperatively in cisplatin-eligible muscle-invasive bladder cancer.

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📢 The Phase 3 Trial Update! 🔹Immunome announced positive topline Phase 3 results from the RINGSIDE trial, with Varegacestat significantly improving PFS vs placebo in desmoid tumors (HR 0.16; p<0.0001). 🔹The registrational study also met all key secondary endpoints, achieving a 56% ORR.

📢 The Phase 3 Trial Update! 🔬 Orca Bio announced Phase 3 Precision-T data published in Blood showing Orca-T® significantly improved survival free from chronic GvHD in patients with AML, ALL, and MDS vs conventional allo-HSCT.

🎗️ The Phase 3 Trial Update! 🔬Enhertu (trastuzumab deruxtecan) in combination with pertuzumab becomes the first new 1L treatment in a decade for HER2-positive metastatic breast cancer. 🚀 The combo reduced the risk of progression or death by 44% vs THP, with median PFS exceeding 3 years.

📢 The Phase 3 Trial Update! 🔬 Proton therapy shows a survival benefit in head & neck cancers, with 5-year survival of 90.9% vs 81% with traditional photon radiation. 🚀 Better quality of life reported; less feeding tube dependence, higher immune cell counts in the largest randomized trial to date.

🚨 The FDA Approval Alert! ✅ FDA approves Niraparib + abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. 🔔 Approval based on improved investigator-assessed rPFS, with OS evaluated as an additional efficacy endpoint.

📢 The Phase 3 Study Update! 🔬 Phase 3 STAR-221 (domvanalimab combo) in upper GI cancers will be discontinued due to futility, as the company sharpens its R&D focus. 🚀 Advancing Casdatifan (HIF-2α inhibitor) with multiple data readouts expected in 2026, expanding I&I diseases programs.

🎗️New in #Oncology! ✅ Lilly’s Inluriyo™ (imlunestrant) shows reinforced efficacy as monotherapy and with Verzenio® (abemaciclib) in ER+, HER2- advanced breast cancer. 🔹Including an 11.4-month OS improvement vs endocrine therapy in ESR1-mutated disease.

📢 New ASCO Guideline Update: Managing Cancer During Pregnancy 🔍 ASCO releases comprehensive guidance on treating cancer during pregnancy, based on a systematic review of 450 studies, including observational data, case series, and case reports.

🚨The CANOVA Phase III Results in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma (RRMM): 🔔 Venetoclax–dexamethasone did not meet the primary PFS endpoint, but showed numerically longer PFS and OS vs pomalidomide–dexamethasone in relapsed/refractory multiple myeloma.

🎗️New Phase III Trial Update! 🔔 Post-neoadjuvant trastuzumab deruxtecan (T-DXd) significantly improved invasive DFS compared with trastuzumab emtansine (T-DM1) in patients with high-risk residual disease. 🔍 Safety notes: GI and hematologic toxicities observed.

🎗️New Phase III PALLAS Study Update! 🔔 Signatera™ MRD testing delivers strong post-surgical prognostic insights for patients with high- and intermediate-risk HR+/HER2- breast cancer. 🔬Post-surgery MRD status provides meaningful risk stratification beyond existing clinical and genomic tools.

🎗️New in #Oncology! ✅ Roche’s Giredestrant is the only oral SERD to show superior invasive DFS in the adjuvant setting, marking the first significant endocrine therapy. 📘Data will be featured in an oral presentation at the 2025 SABCS and included in the official press programme.

🎗️New Phase III Study Update! 📊 1 in 4 metastatic breast cancer patients on Novartis Kisqali® (ribociclib) remain progression-free beyond 4 years. 📈 Kisqali continues to be the only CDK4/6i with consistent OS benefits across all major trials.

🚨New Phase III Study Update! 🔔 TUKYSA® (tucatinib) + trastuzumab + pertuzumab extended median PFS by 8+ months and cut the risk of progression by 36% in the Phase 3 HER2CLIMB-05 study. 📊 The combination showed manageable safety as a 1L maintenance therapy for patients with HER2-positive MBC.

🚨Breaking Clinical Update: RJBC-1501 Trial in Early-Stage TNBC 🔹 Adding carboplatin to adjuvant epirubicin plus cyclophosphamide followed by taxane (EC-T) significantly improved DFS, DDFS, and OS after 4.5 years of follow-up in patients with early-stage TNBC.

🚨 BRUIN CLL-313 Study Highlights! 🧬 Pirtobrutinib outperformed bendamustine plus rituximab (BendaR) in progression-free survival for untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), with a favorable overall benefit trend.

🚨 Latest Oncology update from #ASH2025! ✅ MaaT013 (Xervyteg®) shows durable survival benefit, achieving 54% 1-year OS in high-risk steroid + ruxolitinib-refractory aGvHD patients. 📌 Phase 3 ARES results now presented at #ASH2025. EMA review in progress with a decision expected mid-2026.

🚨 Phase III STARGLO Study Update! 🔔 3-year follow-up of the study shows 2x longer OS with Columvi® (glofitamab) combination in R/R DLBCL patients not eligible for transplant. 🌍 Approved in 50+ countries and globally guideline-recommended. 🔗 Read more: bit.ly/ONCOnews10D-02

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🚨 Latest Oncology update from #ASH2025! 📈 Phase 3 trial shows EPKINLY® (epcoritamab-bysp) + R2 delivers meaningful clinical benefit in relapsed/refractory follicular lymphoma patients. 🧬 Results reinforce promise of epcoritamab-based combinations for tougher-to-treat FL cases.

🚨 Latest Oncology update from #ASH2025! 🩸 Yescarta®(axicabtagene ciloleucel) shows consistent safety & quality of life benefits across a broad range of R/R large B-cell lymphoma patients. 🔬 Strong outcomes seen regardless of transplant eligibility, expanding treatment potential for more patients.

🚨 Latest Oncology update from #ASH2025! 🩸 Phase 3 VERIFY trial shows Rusfertide maintains sustained hematocrit control and strong response rates through 52 weeks, with no new safety signals in Polycythemia Vera. ➡️ Patients switching from placebo also achieved high response rates.

🚨 Latest Oncology update from #ASH2025! 🩸 Lilly's Jaypirca (pirtobrutinib) delivers promising results in the first-ever head-to-head Phase 3 comparison vs. Imbruvica (ibrutinib), achieving a higher ORR in CLL/SLL patients previously treated with a BTK inhibitor.

🚨 Latest Oncology Update from #ASH2025 ! 🩸HYMPAVZI® (marstacimab) reduced bleeds by 93% vs. on-demand treatment in adults/adolescents with Hemophilia A or B with inhibitors. 📊 Results from a Phase 3 study were presented at American Society of Hematology Annual Meeting and published in Blood.

🔔 New update on #FDAApproval ! ✅ FDA approves lisocabtagene maraleucel (Breyanzi) for adults with R/R marginal zone lymphoma after ≥2 prior systemic therapies. 📌 Approval supported by TRANSCEND FL-MZL Cohort trial, delivering a new CAR-T option for patients with limited treatment choices.

🚨 Latest Phase III trial update! 🧬 ctDNA may guide adjuvant decisions in Stage III Colon Cancer. ➡️ Post-hoc analysis from CALGB/SWOG 80702 suggests circulating tumor DNA status could help identify patients who may benefit from adding celecoxib to standard chemotherapy.

🚨 Final Phase III results are in! ➡️ Adding atezolizumab to bevacizumab + non-platinum chemo did not significantly improve OS or PFS in platinum-ineligible recurrent ovarian cancer. 📌 Safety profile remained consistent with known data.

🔔 New update on #FDAApproval ! ✅ U.S. FDA expands approval for Lilly’s Jaypirca (pirtobrutinib) now for adults with relapsed/refractory CLL/SLL after covalent BTKi therapy. 📌 Backed by Phase 3 BRUIN CLL-321 results, broadening access for more patients per NCCN guidance.

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🚨#FDAApproval alert! ✅ FDA Approves IsoPSA® — a Novel Blood-Based Test for Prostate Cancer Detection ➡️ IsoPSA evaluates prostate cancer–specific structural variants of the PSA protein, helping identify high-grade prostate cancer with greater precision.

🚨New in #Oncology! 🔬 STELLAR Phase III Trial Update: A randomized, open-label study evaluating Eflornithine + Lomustine vs. Lomustine alone in patients with recurrent Grade 3 astrocytoma. ✨ Advancing understanding of treatment options in recurrent gliomas. 🔗 Read more: bit.ly/ONCOnews02D-1

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🚨Approval Alert! ✅ Imfinzi (durvalumab) becomes the first perioperative immunotherapy approved in the US for early gastric & GEJ cancers. Phase III MATTERHORN data show strong outcomes: 🔹 29% lower risk of progression, recurrence or reduced OS. 🔹 22% lower risk of reduced OS vs. standard chemo

🚨New in #Oncology! 🔔 PharmaEssentia, announces that positive results from its pivotal Phase 3 SURPASS-ET clinical trial have been published in The Lancet Haematology. ➡️ The SURPASS-ET compared ropeginterferon alfa-2b vs anagrelide in hydroxyurea-resistant/intolerant ET with leukocytosis.

🚨Latest Approval Alert! 🔔 The EC approves expanded use of Breyanzi® (lisocabtagene maraleucel; liso-cel) for R/R Mantle Cell Lymphoma (MCL). 🧬 In the TRANSCEND MCL trial, 82.7% of patients responded, with 71.6% achieving a complete response, and over 50% maintaining response at 24 months.

🚨FDA Approval Update! 🔔 The FDA has approved pembrolizumab in combination with enfortumab vedotin-ejfv as a neoadjuvant + adjuvant treatment for adults with MIBC who are ineligible for cisplatin. 🎯 The major efficacy outcome measure was EFS assessed by blinded independent central review.

🚨FDA Approval Alert! 🔔 FDA grants accelerated approval to Sevabertinib for adults with metastatic non-squamous NSCLC harboring HER2 TKD activating mutations after prior systemic therapy. ➡️ FDA also clears the Oncomine Dx Target Test as a companion diagnostic to identify eligible patients.

🚨FDA Approval Alert! 🔔 The FDA has granted full approval to daratumumab and hyaluronidase-fihj plus VCd for newly diagnosed light chain (AL) amyloidosis, converting its 2021 accelerated approval to traditional approval. ✅ This decision is supported by results from the ANDROMEDA Phase 3 trial.

🚨FDA Approval Alert! 📢 FDA approves selumetinib(KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with NF1 experiencing symptomatic, inoperable plexiform neurofibromas. 🔹FDA previously approved selumetinib capsules and granules for pediatric patients 1 year of age and older for this indication.

🚨European Union Approval Alert! ✅ EU approves Libtayo® (cemiplimab) as the first immunotherapy for adjuvant treatment of CSCC at high risk of recurrence after surgery and radiation. 📉 Phase 3 C-POST trial: Significant improvement in disease-free survival with a 68% reduction in recurrence.

🚨FDA Approval Alert! ✅ FDA grants full approval to Amgen's IMDELLTRA® (tarlatamab-dlle) in extensive stage small cell lung cancer (ES-SCLC). 🎯 Phase 3 DeLLphi-304 shows 40% reduction in risk of death vs chemo. 🔗 Read more: bit.ly/ONCOnews20N3 #ONCOnews #OncoAlert #OncEd #Oncology #CancerUpdates

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🚨Latest in Oncology! 🆕 EU approves Roche’s Lunsumio® (mosunetuzumab) subcutaneous (SC) for relapsed/refractory follicular lymphoma — offering durable responses even in later-line disease. ⏱️ New SC option cuts administration time to ~1 minute, supporting greater treatment flexibility for patients.

🚨New EC Approval! 🔔 The European Commission has approved subcutaneous KEYTRUDA® (pembrolizumab) for all adult EU-approved indications — becoming the first and only subcutaneous immune checkpoint inhibitor in Europe. 🔗 Read more: bit.ly/ONCOnews20N-1 #ONCOnews #OncoAlert #OncEd #Oncology