Izalontamab Brengitecan Earns FDA Breakthrough Designation in EGFR+ NSCLC The FDA designates iza-bren as a breakthrough therapy for advanced EGFR-mutant NSCLC, promising improved outcomes for patients with limited options.

The FDA designates iza-bren as a breakthrough therapy for advanced EGFR-mutant NSCLC, promising improved outcomes for patients with limited options. Read the full story here → www.targetedonc.com/view/izalont...

Neoadjuvant Pembrolizumab and Enfortumab Vedotin Improve Outcomes in MIBC New trial results reveal that pembrolizumab and enfortumab vedotin significantly enhance survival rates for muscle-invasive bladder cancer patients ineligible for cisplatin.

New trial results reveal that pembrolizumab and enfortumab vedotin significantly enhance survival rates for muscle-invasive bladder cancer patients ineligible for cisplatin. Read more→ www.targetedonc.com/view/neoadju...

FDA Grants Accelerated Approval to Zongertinib in HER2 NSCLC Zongertinib gains FDA approval for advanced NSCLC with HER2 mutations, showcasing promising efficacy and safety in clinical trials.

The FDA has granted accelerated approval to #zongertinib in HER2+ #NSCLC. Read about the breaking regulatory decision here → www.targetedonc.com/view/fda-gra...

Dordaviprone Receives Accelerated FDA Approval for Diffuse Midline Glioma Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

BREAKING NEWS: The FDA granted accelerated approval to dordaviprone (Modeyso) for adult and pediatric patients with diffuse midline glioma, marking a major step forward in this patient population. Read more about the approval here → www.targetedonc.com/view/dordavi...

July's Oncology Approvals: A Landmark Month for Cancer Treatment Advancements July marks a transformative month in oncology with the FDA's groundbreaking approvals and updates, enhancing treatment options for various cancers.

July marked a transformative month in oncology with the FDA's groundbreaking approvals and updates, enhancing treatment options for various cancers. Read up on all of the FDA happenings in our monthly recap: www.targetedonc.com/view/july-20...

Optimizing CLL/SLL Therapy: Pirtobrutinib Matches Ibrutinib in Phase 3 Pirtobrutinib shows promising results in treating CLL, outperforming ibrutinib in a pivotal phase 3 trial, paving the way for broader applications.

Game-changer in CLL/SLL? Pirtobrutinib's Phase 3 data reveals it's matching and potentially outperforming ibrutinib in ORR. Its noncovalent mechanism is key for overcoming resistance. A promising development for our clinical community. www.targetedonc.com/view/optimiz...

Ateganosine Receives FDA Fast Track Designation for NSCLC Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

Ateganosine has received FDA Fast Track designation for advanced NSCLC progressing after ICI therapy. This novel telomere-targeting agent is showing promising early clinical data. Explore the full article for insights into this critical development. www.targetedonc.com/view/ategano...

Durvalumab Earns FDA Priority Review for Early-Stage Gastric Cancer Durvalumab's breakthrough therapy designation offers hope for improved outcomes in early-stage gastric and GEJ cancers, potentially transforming treatment strategies.

Durvalumab just received FDA Priority Review & Breakthrough Therapy for resectable early-stage gastric/GEJ cancers. This could be the first perioperative immunotherapy in this setting, addressing a high unmet need.

Read the full story here: www.targetedonc.com/view/durvalu...

FDA Grants Priority Review to Tab-cel for EBV+ PTLD After Prior Therapies Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

FDA grants priority review to tabelecleucel for relapsed/refractory EBV+ PTLD, a critical step towards the first approved therapy for this severe posttransplant malignancy. PDUFA date Jan 10, 2026. #EBVPTLD #CellTherapy #FDA #Oncology www.targetedonc.com/view/fda-gra...

The FDA has now pushed its target decision date to October 23, 2025.

This follows last week's FDA ODAC vote against the benefit-risk profile of the agent. The scheduled PDUFA target action date for belantamab mafodotin's BLA in the US was yesterday, July 23.

EU Approves Belantamab Mafodotin Combinations for Relapsed/Refractory Myeloma The EU approves belantamab mafodotin combinations, enhancing treatment options for relapsed multiple myeloma patients with promising efficacy and safety profiles.

The EU approved belantamab mafodotin (Blenrep) combinations in R/R multiple myeloma, enhancing treatment options for relapsed multiple myeloma patients with promising efficacy and safety profiles. Read the full story: www.targetedonc.com/view/eu-appr...

Luspatercept Misses Primary End Point, Shows Clinically Meaningful Secondary Benefits Luspatercept shows promise in improving anemia in myelofibrosis patients, despite not meeting primary trial endpoints, highlighting ongoing treatment challenges.

Luspatercept (Reblozyl) phase 3 INDEPENDENCE trial missed its primary endpoint for RBC transfusion independence but showed promising secondary benefits, like reduced transfusion burden & increased hemoglobin. hubs.li/Q03ycfyx0 #Myelofibrosis #Anemia #ClinicalTrials

FDA Issues CRL for RP1 in Advanced Melanoma Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete response letter.

The FDA has issued a CRL for RP1 in advanced melanoma, primarily due to concerns about the interpretability of the IGNYTE trial's results and questions on the confirmatory trial design. This emphasizes the strict regulatory requirements for new therapies. www.targetedonc.com/view/fda-iss...

Osimertinib Plus Chemotherapy Significantly Extends Survival in Advanced EGFRm NSCLC Osimertinib plus chemotherapy significantly improves overall survival in EGFRm NSCLC, signaling a new standard of care.

Final OS data from FLAURA2 confirm osimertinib + platinum-based chemo significantly extends survival in 1L EGFRm NSCLC. A potential new standard of care. Read more: hubs.li/Q03y1gxQ0 #LungCancer #EGFRm #NSCLC #Oncology #ClinicalTrials

Despite CRL for combination, glofitamab monotherapy remains approved for R/R DLBCL (≥2 prior lines). STARGLO study showed 41% risk reduction in death for combination, published in The Lancet. Stay tuned for future developments. #Oncology #Hematology #ClinicalTrials

FDA Issues Complete Response Letter for Glofitamab in R/R DLBCL Combination Therapy FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in oncology therapy approvals.

FDA issues CRL for glofitamab + GemOx in 2L R/R DLBCL, citing limited US patient enrollment in STARGLO study. Glofitamab retains accelerated approval as monotherapy in later lines. Important regulatory update for clinicians. #Lymphoma #DLBCL #OncTwitter #FDA www.targetedonc.com/view/fda-iss...

Nivolumab Plus AVD Outperforms Brentuximab Vedotin-Based Regimen in Older Patients With Classic Hodgkin Lymphoma A recent trial reveals that nivolumab combined with chemotherapy significantly improves survival rates in older patients with advanced Hodgkin lymphoma.

Thank you, @targetedonc.bsky.social, for reporting on this subset analysis from the @swog.org S1826 trial, recently publ in JCO:
Nivolumab Plus AVD Outperforms Brentuximab Vedotin-Based Regimen in Older Patients With Classic Hodgkin Lymphoma targetedonc.com/view/nivolum...

FDA Grants Accelerated Approval to Dato-DXd in Previously Treated EGFR+ NSCLC FDA accelerates approval of datopotamab deruxtecan for advanced EGFR-mutated NSCLC, offering new hope for previously treated patients.

BREAKING: The #FDA granted accelerated approval to datopotamab deruxtecan (Datroway) for adult patients with locally advanced or metastatic EGFR-mutated #NSCLC who have previously received systemic therapies, including EGFR-targeted treatments.
www.targetedonc.com/view/fda-gra...

@scri.com

#ASCO25 Recap: Immunotherapy takes center stage! Dr. David Spigel shares the key highlights. ▶️ Watch now! #CancerTreatment #SarahCannon

Follow along for real-time updates from #ASCO25 and insights from the ground floor of the world’s leading oncology conference!

www.targetedonc.com/conference/a...

#OncologyInnovation #MedicalOncology #CancerResearch #PrecisionMedicine

Anlotinib Noninferior to Bevacizumab in Frontline RAS/BRAF Wild-Type mCRC Anlotinib plus chemotherapy has emerged as a first-line alternative to bevacizumab/chemotherapy in RAS/BRAF wild-type metastatic colorectal cancer.

Anlotinib showed noninferior PFS vs bevacizumab when either agent was combined with first-line CapeOX chemotherapy in Chinese patients with RAS/BRAF wild-type, unresectable #mCRC, meeting the primary end point of the phase 3 ANCHOR trial. #crcsm #ASCO25
www.targetedonc.com/view/anlotin...

ASCO 2025 Briefing: Advances in Breast, Lung, and Obesity-Linked Cancers The ASCO 2025 press briefing showcased early highlights in cancer therapy. Here’s what you need to know.

Big news from the May 21 #ASCO25 press briefing:

🔹 GLP-1s show cancer risk reduction
🔹 AI boosts HER2-low scoring accuracy
🔹 Inavolisib triplet extends survival in PIK3CA-mutant breast cancer
🔹 Lurbinectedin combo shows OS/PFS gains in SCLC

www.targetedonc.com/view/asco-20...

Unmet Needs and Therapy Modifications Relevant in the CRC Landscape John L. Marshall, MD, discusses unmet needs in the targeted therapy space and the importance of optimizing dosing in colorectal cancer.

John L. Marshall, MD, (@marshalj23.bsky.social) discusses unmet needs in the targeted therapy space and the importance of optimizing dosing in colorectal cancer with @targetedonc.bsky.social. www.targetedonc.com/view/unmet-n...

Clinical Trial Awareness Day: Progress in Brain Cancer Research Manmeet Ahluwalia, MD, MBA, FASCO, highlights genomic testing as a crucial area of current research with immediate implications for patients with brain cancer.

Today is #ClinicalTrialsDay! Here, Manmeet Ahluwalia, MD, MBA, FASCO, highlights genomic testing as a crucial area of current research with immediate implications for patients with brain cancer.

www.targetedonc.com/view/clinica...

FDA Approves Retifanlimab, First Frontline Treatment for Advanced SCAC With significant survival improvements seen, the FDA has granted approval to retifanlimab for the first-line treatment of advanced anal cancer.

BREAKING: The #FDA has approved retifanlimab-dlwr for the treatment of advanced squamous cell carcinoma of the anal canal as a monotherapy and in combination with chemotherapy. #SCAC
www.targetedonc.com/view/fda-app...

The Targeted Pulse: New Therapies for Melanoma, Myeloma, and More The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

The Targeted Pulse: The #FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

www.targetedonc.com/view/targete...

FDA Accepts Narsoplimab BLA Resubmission for Transplant-Associated TMA The resubmitted biologics license application for narsoplimab in transplant-associated thrombotic microangiopathy has been accepted by the FDA.

The #FDA has accepted the biologics license application resubmission for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy.

www.targetedonc.com/view/fda-acc...

FDA Issues Refusal to File for Nogapendekin Alfa Plus BCG in Papillary NMIBC The FDA issued an RTF for sBLA of nogapendekin alfa plus BCG for BCG-unresponsive NMIBC papillary disease, following prior positive feedback.

The #FDA has issued a refusal to file letter for the supplemental biologics license application seeking approval of nogapendekin alfa inbakicept in combination with Bacillus Calmette-Guérin. #blcsm

www.targetedonc.com/view/fda-iss...
www.targetedonc.com/view/fda-iss...