Weekly Oncology Highlights | Oncology News, Updates and Spotlights

by | Aug 1, 2025 | EU approvals, FDA approvals, News, Oncology news, Oncology Updates

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Your go-to digest for the latest breakthroughs in cancer care.

This week’s digest spans EU approvals in myeloma and lung cancer, precision-driven trials in breast and hematologic oncology, and a biomarker breakthrough in lung adenocarcinoma brain metastasis.

Leading voices. Big insights. Scroll down for Dr. Maria Barbu!

 

Sarclisa (Isatuximab) Gains EU Approval in Transplant-Eligible Newly Diagnosed Multiple Myeloma

On July 25, 2025, the European Commission approved Sarclisa combined with VRd (bortezomib, lenalidomide, dexamethasone) as induction therapy for transplant-eligible NDMM. The GMMG-HD7 Phase III trial showed significant MRD negativity and prolonged progression-free survival versus VRd alone.
Clinical insight: This approval broadens Sarclisa’s role to include early disease lines, regardless of transplant eligibility.
(Ref: Sanofi press release citing GMMG-HD7 results and EC approval, July 25, 2025)

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CHMP Recommends TEVIMBRA (Tislelizumab) for Resectable NSCLC (RATIONALE-315) Trial

On July 28, 2025, CHMP issued a positive opinion for TEVIMBRA plus platinum-based chemo as neoadjuvant therapy followed by adjuvant monotherapy in high-risk resectable NSCLC. In the Phase III RATIONALE‑315 trial, TEVIMBRA significantly improved MPR (56.2% vs 15.0%), pCR (40.7% vs 5.7%), and event-free survival (HR 0.56; P=0.0003).
Practice relevance: Could establish the first perioperative immunotherapy standard in early-stage NSCLC.
(Ref: BeOne Medicines CHMP recommendation release, July 28, 2025)

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TEODOR Trial Launched to Evaluate ct-DNA Guided  De-escalation in HR+ Breast Cancer

Natera and ABCSG have initiated the TEODOR Phase II RCT, investigating whether hormone receptor-positive, HER2-negative patients who are ctDNA-negative and endocrine-responsive can safely skip neoadjuvant chemotherapy in favor of endocrine therapy. Primary endpoints are pCR rate and modified PEPI score.
Innovative approach: Personalizes neoadjuvant decision-making via ctDNA and endocrine sensitivity metrics.
(Ref: Natera press release announcing TEODOR trial launch, July 29, 2025)

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Pirtobrutinib (Jaypirca) Meets Primary Endpoint Against Ibrutinib in First-Line CLL/SLL (BRUIN CLL-314)

On July 29, 2025, Lilly announced that pirtobrutinib demonstrated non-inferiority and statistical superiority, in overall response rate versus ibrutinib in treatment-naïve or BTKi-naïve CLL/SLL, in the head-to-head BRUIN CLL‑314 Phase III trial. PFS data is immature but trending favourably.
Clinical takeaway: This is first head-to-head evidence supporting a non-covalent BTK inhibitor in frontline CLL/SLL.
(Ref: Lilly press release with BRUIN trial topline results, July 29, 2025)

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Neuronatin (NNAT) Overexpression Predicts Brain Metastatis and Poor Survival in Lung Adenocarcinoma

A retrospective study of 200 lung adenocarcinoma patients (33 with brain metastasis) showed that nuclear NNAT immunopositivity corresponded with significantly shorter overall survival (7.6 vs 24.4 months) and independently predicted brain metastasis risk. NNAT-IRS positivity was similarly linked to diminished outcomes.
Translational insight: NNAT may serve as a valuable early prognostic biomarker to stratify high-risk patients for brain-directed surveillance and intervention.
(Ref: Basaran Goksen et al. Scientific Reports 2025;15:27653)

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This week’s Oncology Spotlight: Dr. Maria Barbu on Cancer Care in Romania!

In this week’s special segment from IUCS 2024, we speak with Dr. Maria Barbu, a medical oncologist from Bucharest, Romania. CLICK HERE TO WATCH!Oncology Spotlight 45 1Dr. Barbu shares her perspective on the evolving oncology landscape in Eastern Europe, particularly in the treatment of prostate cancer.Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away. 

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

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  •  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
  • Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

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Weekly Oncology Highlights | Oncology News, Updates and Spotlights

by | Jul 25, 2025 | EU approvals, FDA approvals, News, Oncology news, Oncology Updates

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Your go-to digest for the latest breakthroughs in cancer care.

This week’s updates spans EU precision approvals in prostate and breast cancer, immunotherapy-driven de-escalation in cSCC, and generic access gains, underscoring strides toward personalized, accessible oncology care.

Leading voices. Big insights. Scroll down to watch now Dr. Vinayak Maka’s Oncology Spotlight!

EU Approves Nubeqa (Darolutamide) for Metastatic Hormone-Sensitive Prostate Cancer 

On July 21, 2025, the European Commission approved Nubeqa™ (darolutamide) plus ADT in mHSPC, based on the Phase III ARANOTE trial showing a 46% reduction in radiographic progression or death (HR 0.54; 95% CI 0.41–0.71; P < 0.0001). The safety profile was consistent with published data, and the indication now supports use with or without chemotherapy.
Clinical insight: Offers flexibility to tailor therapy intensity in mHSPC patients.
(Ref: Bayer press release reporting ARANOTE outcomes and EC approval, July 21, 2025)

Blenrep (Belantamab Mafodotin) Combinations Approved in EU for Relapsed/Refractory Multiple Myeloma

In relapsed/refractory multiple myeloma after ≥ 1 prior therapy (including prior lenalidomide for BPd), the European Commission approved Blenrep + bortezomib + dexamethasone (BVd) and Blenrep + pomalidomide + dexamethasone (BPd) on July 24, 2025. Head-to-head Phase III DREAMM‑7 and DREAMM‑8 trials showed superior progression-free survival, with DREAMM‑7 also demonstrating a ~42% overall survival benefit compared to daratumumab-based triplets. Ocular events were common but manageable; discontinuation rates were ≤ 9%, and non‑ocular AEs included thrombocytopenia, neutropenia, diarrhoea and COVID‑19.
Practice shift: Blenrep becomes the first anti‑BCMA ADC combination approved in the EU, offering substantial PFS/OS gains and outpatient-friendly administration in the earliest relapsed setting, redefining options post–first relapse.
(Ref: GSK press releases and CHMP positive opinion based on DREAMM‑7/8 efficacy and safety data; Reuters on EU approval and global context)

EC Approves Itovebi™ (Inavolisib) for PIK3CA‑Mutated HR‑Positive, HER2‑Negative Advanced Breast Cancer 

On July 23, 2025, the European Commission approved Inavolisib combined with palbociclib and fulvestrant for adults with PIK3CA-mutated, ER-positive, HER2-negative advanced breast cancer relapsing within 12 months post-endocrine therapy. The INAVO120 Phase III data showed 57% PFS improvement (HR 0.43; median 15.0 vs 7.3 months; P < 0.001), 33% OS benefit (HR 0.67; P = 0.019), and delayed chemotherapy initiation by approximately two years.
Impact: First PI3K-targeted therapy delivering both PFS and OS benefit in this biomarker-defined subgroup, underscores upfront genomic testing.
(Ref: Roche and EMA documentation of INAVO120 final OS analysis and EC approval, July 2025)

EC Approves DARZALEX® (Daratumumab SC) for High‑Risk Smouldering Multiple Myeloma

On July 23, 2025, the European Commission authorized subcutaneous daratumumab as first licensed monotherapy for high-risk smouldering multiple myeloma. The Phase III AQUILA study demonstrated a 51% reduction in progression to active MM or death versus observation.
 Breakthrough: Establishes the first early-intervention, approved therapeutic for high-risk SMM.
(Ref: CHMP positive opinion and EC approval based on AQUILA outcomes as reported by Janssen in mid‑2025 )

ECUS FDA Tenatatively Approves Zydus Generic Ibrutinib Tablets for CLL/SLL 

On July 24, 2025, Zydus Lifesciences received tenatative U.S. FDA approval for generic Ibrutinib tablets in all three strenghts for CLL/SLL with 17p deletion and Waldenstrom’s macroglobulinemia. Branded Ibrutinib annual U.S. sales are estimated at USD 2.15 billion. Significance: Paves way for broader access and cost reduction in BTK- inhibitor therapy upon patent expiry. (Ref: FDA tenatative approval report and market analysis in targeted oncology news, July 24, 2025)

This week’s Oncology Spotlight: Dr. Vinayak Maka on using the ONCOassist app!

In this podcast, as one of our earliest users in India, Dr. Maka shares how the app transformed the way he accesses staging systems, toxicity grading, oncology calculators, and real-time updates at the point of care.Oncology Spotlight 45 2  Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.     

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

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  •  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
  • Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

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CLICK HERE FOR LATEST ONCOLOGY UPDATES
Weekly Oncology Highlights – Powered by ONCOassist

Weekly Oncology Highlights – Powered by ONCOassist

by | Jul 18, 2025 | News

Your go-to digest for the latest breakthroughs in cancer care.

 

From breakthrough PARP/AR combo efficacy to transformative immunotherapy approvals and rare cancer strides, this week’s oncology updates spotlight how precision therapies and regulatory momentum are setting new benchmarks in survival and patient outcomes.

Leading voices. Big insights. Scroll down to watch now Dr. Akash Maniam’s Oncology Spotlight!

 

TALAPRO-2: Talazoparib + Enzalutamide Survival Breakthrough in mCRPC

A final overall survival analysis from the phase III TALAPRO‑2 trial showed that talazoparib plus enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer reduced risk of death by 38% (HR 0.62; p = 0.0005), extending median OS to 45.1 vs 31.1 months compared to placebo + enzalutamide.

Safety profile consistent: grade 3+ anemia (43%), neutropenia (20%); no new safety signals. (Reference: Fizazi et al., The Lancet, 2025 Final OS Analysis)

TEVIMBRA® (Tislelizumab) Approved in EU for Nasopharyngeal Carcinoma Based on RATIONALE-309

The European Commission approved tislelizumab (TEVIMBRA®) with gemcitabine and cisplatin as first-line therapy for metastatic/recurrent nasopharyngeal carcinoma not suitable for curative treatment.

(Reference: BeOne Medicines Ltd., “European Commission Approves TEVIMBRA® in Combination with Chemotherapy as a First‑Line Treatment for Nasopharyngeal Carcinoma,” July 10, 2025)

ENGOT‑OV60/RAMP 201: Avutometinib + Defactinib in Recurrent Low‑Grade Serous Ovarian Cancer 

Results from the phase II ENGOT‑OV60/GOG‑3052/RAMP 201 study, published in JCO, showed that the oral combination of MEK inhibitor avutometinib plus FAK inhibitor defactinib induced a 31% confirmed ORR in 115 heavily pretreated patients with recurrent low-grade serous ovarian cancer (LGSOC), including complete and partial responses. Notably, KRAS-mutant tumors responded at 44%, compared with 17% in wild-type cases. Median progression-free survival was 12.9 months overall, extending to 22.0 months in the KRAS-mutant cohort versus 12.8 months in the wild-type group. The safety profile was manageable; common grade ≥3 AEs included elevated CPK (24%), diarrhea (8%), and anemia (5%), while approximately 10% discontinued due to toxicity. (Reference: Banerjee et al., JCO, 2025)

ICR Identifies New “Armour” Protein (SLC7A11) in Melanoma

The Institute of Cancer Research (UK) identified SLC7A11 as a protective protein that shields melanoma cells from oxidative stress and enhances invasive potential. Elevated SLC7A11 maintains cytoskeletal dynamics essential for amoeboid movement and metastasis. Notably, in vitro inhibition killed ~75% of melanoma cells within 72 hours, suggesting a promising therapeutic target. The researchers also caution that antioxidant supplements (e.g., glutathione) may reinforce this “armour” and should be used judiciously in melanoma patients. (Reference: ICR press release, July 15, 2025)

FDA grants Fast Track to ZEN-3694 + Abemaciclib for NUT Carcinoma

On July 14, the FDA awarded Fast Track designation to the BET inhibitor ZEN‑3694, in combination with abemaciclib, for treatment of metastatic or unresectable NUT carcinoma following prior chemotherapy. This ultra‑rare, aggressive cancer lacks approved systemic therapies. Preclinical and early clinical data support the combination’s potency, and FDA Fast Track status will facilitate expedited review via priority communication and potential accelerated approval mechanisms. (Reference: Zenith Epigenetics Ltd. press release, July 14, 2025)

This week’s Oncology Spotlight: Dr. Akash Maniam compares the Oncology Systems and Cancer Care of UK and the Caribbean

In this podcast, Dr. Akash Maniam contrasts cancer care in the UK with that in the Caribbean, spotlighting challenges from diagnostic delays to limited trial access and geographic barriers. Oncology Spotlight 45 1His insights underscore the urgent need for global oncology equity, especially in low‑resource settings where systemic gaps and lack of auditing hinder outcomes.   Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.     

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !

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  •  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
  • Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 

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Weekly Oncology Highlights – Powered by ONCOassist

Weekly Oncology Highlights – Powered by ONCOassist

by | Jul 11, 2025 | News

Your go-to digest for the latest breakthroughs in cancer care.

 

From a landmark EU approval of perioperative immunotherapy in bladder cancer to strong CAR‑T durability and promising oral regimens in haematological malignancies, this week’s oncology updates show how targeted drugs and regulatory advances are driving better survival and improves patient outcomes.

Leading voices. Big insights. Scroll down to watch now Dr. Grant Jirka’s Oncology Spotlight!

 

Imfinzi (Durvalumab) Gains EU Approval in Muscle-Invasive Bladder Cancer Based on NIAGARA Trial Results

The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy, for adult patients with resectable muscle-invasive bladder cancer (MIBC).

This regulatory nod follows results from the Phase III NIAGARA trial, which demonstrated a 32% reduction in risk of disease progression, recurrence, or death (HR 0.68; 95% CI, 0.56–0.82; p<0.0001) and a 25% reduction in risk of death (HR 0.75; 95% CI, 0.59–0.93; p=0.0106) compared to neoadjuvant chemotherapy alone. At two years, 82.2% of patients treated with the Imfinzi regimen were alive, and 67.8% were event-free.

Imfinzi was well tolerated, with no new safety signals, and was consistent with known profiles in neoadjuvant and adjuvant settings. The ESMO Magnitude of Clinical Benefit Scale (MCBS) awarded this regimen the highest grade of “A” in the curative setting. Regulatory submissions are ongoing in Japan and other countries. (Reference: AstraZeneca. “Imfinzi Approved in the EU Based on NIAGARA Phase III Results.” July 2025)

 

STAMPEDE Trial: Metformin Shows No Significant Survival Benefit in mHSPC, But Reduces ADT-Related Metabolic Effects

In the latest arm of the STAMPEDE platform Phase III trial, the addition of metformin (850 mg BID) to standard of care (SOC) in non-diabetic patients with metastatic hormone-sensitive prostate cancer (mHSPC) did not significantly improve overall survival (HR 0.91; 95% CI, 0.80–1.03; p=0.15), although median survival was numerically longer: 67.4 months vs. 61.8 months in the SOC group.

However, metformin significantly reduced adverse metabolic effects commonly seen with androgen deprivation therapy (ADT), such as weight gain and metabolic derangements. Grade 3 or worse gastrointestinal side effects were higher in the metformin group (9% vs. 7%).

While not practice-changing, the findings underscore metformin’s metabolic safety benefits and its potential utility in settings where ARPI access is limited due to cost or comorbidities. (Reference: Gillessen S. et al. “STAMPEDE Trial: Metformin in Metastatic Prostate Cancer.” The Lancet Oncology, July 2025)

 

Taiho’s INQOVI (decitabine and cedazuridine) + Venetoclax Accepted by FDA for AML Review 

The U.S. FDA has accepted Taiho Oncology’s supplemental new drug application (sNDA) for INQOVI (decitabine and cedazuridine) in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults ineligible for intensive induction chemotherapy. A standard review has been assigned with a PDUFA action date of February 25, 2026.

The submission is supported by ASCERTAIN-V (AStx727-07), a Phase 2b trial involving 101 patients, where INQOVI was administered on days 1–5 of a 28-day cycle and venetoclax daily. The trial met its primary endpoint with a complete response (CR) rate of 46.5%, while CR + CRi was 63.4%. Median overall survival was 15.5 months; at 12 months, over 75% of patients who achieved CR remained in CR.

Safety was consistent with known profiles of both agents, with no new safety signals or drug-drug interactions reported. Grade ≥3 adverse events occurred in 98% of patients, with febrile neutropenia (49.5%), anemia (38.6%), and neutropenia (35.6%) being most common.

If approved, this would be the first all-oral regimen for patients with AML who are not eligible for standard induction therapy. (Reference: Taiho Oncology Press Release, July 9, 2025; data presented at ASCO & EHA 2025)

 

TRANSFORM 3-Year Update Confirms Durable Benefit of Lisocabtagene Maraleucel in Second-Line LBCL

The Phase III TRANSFORM trial (NCT03575351) evaluating lisocabtagene maraleucel (liso-cel) versus standard of care (SOC) in second-line relapsed/refractory large B-cell lymphoma (LBCL) with ≤12 months of relapse post first-line therapy has reported 3-year follow-up data.

Median event-free survival (EFS) was 29.5 months with liso-cel vs. 2.4 months with SOC (HR 0.375; 95% CI, 0.259–0.542). The 3-year progression-free survival (PFS) rates were 51% vs. 26.5%, respectively. While overall survival (OS) was not reached in either arm, a crossover-adjusted OS HR of 0.566 (95% CI, 0.359–0.895) favored liso-cel.

Safety remained consistent with earlier reports, with no new safety signals. These findings reinforce liso-cel’s curative potential as a second-line therapy in LBCL. (Reference: Kamdar M. et al. “Three-Year Results from the TRANSFORM Trial.” Journal of Clinical Oncology, July 2025)

 

Divarasib Shows Durable Activity in KRAS G12C+ NSCLC With Favourable Long-Term Safety

Updated data from a Phase I study (NCT04449874) of divarasib (GDC-6036) in KRAS G12C–mutated non-small cell lung cancer (NSCLC) showed long-term antitumor activity and sustained safety beyond 1 year.

Among 65 patients, the objective response rate (ORR) was 55.6%, and median duration of response (DoR) reached 18.0 months. The median progression-free survival (PFS) was 13.8 months overall, and 15.3 months at the 400 mg dose level.

Divarasib, a next-generation KRAS G12C inhibitor, exhibited a favorable safety profile and high selectivity. Its extended activity profile supports its promise as a potentially superior alternative to current KRAS G12C inhibitors. (Reference: Sacher A. et al. “Divarasib in KRAS G12C–Positive NSCLC: Long-Term Results.” Journal of Clinical Oncology, July 2025)

 

This week’s Oncology Spotlight: Dr.Grant Jirka shares his insights on ONCOassist’s Advanced Myelofibrosis Scoring Tool

In a recent video feature, Dr. Grant Jirka, Hematology/Oncology Fellow in Los Angeles, demonstrates how the ONCOassist Advanced Myelofibrosis Scoring Tool is streamlining clinical decision-making in one of hematology’s most challenging diseases. Oncology Spotlight 45By integrating five major prognostic models IPSS, DIPSS, DIPSS-Plus, MIPSS70, and MIPSS70-Plus, into a single, intuitive interface, the tool allows oncologists to input 12 variables and receive comprehensive risk stratification in under 90 seconds. From simplifying transplant discussions to supporting more confident, informed treatment planning, this tool is a game-changer in managing myelofibrosis.

 

 

Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.     

Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !
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  •  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
  • Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 
Download the app here:

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Weekly Oncology Highlights – Powered by ONCOassist

Weekly Oncology Highlights – Powered by ONCOassist

by | Jul 4, 2025 | News

Your go-to digest for the latest breakthroughs in cancer care.

 
From targeted therapies to regulatory shifts, these five developments highlight how precision oncology is reshaping standards of care, empowering clinicians with new tools and broader accessibility.
Leading voices. Big insights. This episode of Oncology Spotlight delivers—scroll down to watch now!

 

Revolution Medicines Lands FDA Breakthrough for Daraxonrasib in KRAS G12‑Mutant Metastatic Pancreatic Cancer

The FDA has granted Breakthrough Therapy designation to Daraxonrasib, an oral RAS(ON) inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12X mutations. In Phase 1 (RMC-6236-001), second‑line metastatic PDAC (progressed within six months of prior therapy), median PFS was 8.1 months (95% CI, 5.9–NE) for KRAS G12X and 7.6 months (95% CI, 5.3–NE) for all RAS‑mutated cases. For third‑line or later treatment with RMC‑6236, median PFS was 4.2 months (95% CI, 4.1–6.4). Among second‑line+ patients with KRAS G12X, ORR reached 20% (16/79) at ≥14 weeks and 27% (13/48) at ≥20 weeks, with a 14‑week DCR of 87%. 

The global Phase 3 RASolute‑302 trial is ongoing, comparing daraxonrasib to standard chemotherapy in G12X (plus expanded G13X and Q61X) cohorts, with dual primary endpoints of PFS and OS. Topline results are expected in 2026. (Reference: Revolution Medicines, Inc. “Revolution Medicines Announces FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations.” GlobeNewswire, 23 June 2025)

Amgen Reveals Positive Phase 3 Bemarituzumab Data in FGFR2b-positive Gastric Cancer

Amgen’s Phase III FORTITUDE‑101 trial met its primary endpoint, demonstrating a significant overall survival benefit when Bemarituzumab was added to mFOLFOX6 in FGFR2b-overexpressing, HER2-negative gastric or gastroesophageal junction cancer.
 The 547-patient study selected tumors with ≥10% FGFR2b positivity; ocular events (like keratitis and vision changes) and hematologic toxicities were more common in the treatment arm. Detailed efficacy and safety data, along with results from an upcoming chemo+nivolumab combo study, are expected later this year. (Reference: Amgen Announces Positive Topline Phase 3 Results for Bemarituzumab in Fibroblast Growth Factor Receptor 2b (FGFR2b)‑Positive First‑Line Gastric Cancer.” Amgen Press Release, 30 June 2025.)

FDA Lifts REMS for CAR‑T Therapies

As of June 27, the FDA removed REMS requirements for all FDA-approved BCMA- and CD19-directed autologous CAR‑T therapies—Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, and Yescarta .
 Key changes:

(Reference: U.S. Food and Drug Administration. “FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T Cell Immunotherapies.” FDA Press Release, 27 June 2025.)

FDA Grants Accelerated Approval to Sunvozertinib (Zegfrovy) for EGFR Exon 20+ NSCLC

On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations, following disease progression on platinum-based chemotherapy.
 In the WU‑KONG1B trial (n=85), sunvozertinib showed a 46% ORR and median duration of response of 11.1 months. The FDA also approved a companion diagnostic to identify eligible patients. (Reference: U.S. Food and Drug Administration. “FDA Grants Accelerated Approval to Sunvozertinib for Metastatic Non‑Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.” FDA Press Release, 2 July 2025.)

Lynozyfic (Linvoseltamab‑gcpt) Joins Myeloma Armamentarium

The FDA granted accelerated approval to Linvoseltamab‑gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.) on July 2, 2025, for adult patients with relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, IMiD, and anti‑CD38 antibody.
 In the LINKER‑MM1 trial, the BCNMA×CD3 engager achieved a 70% ORR, With a median follow-up of 11.3 months among responders, the estimated duration of response (DOR) was 89% (95% CI: 77, 95) at 9 months and 72% (95% CI: 54, 84) at 12 months. (Reference: U.S. Food and Drug Administration. “FDA Grants Accelerated Approval to Linvoseltamab‑gcpt for Relapsed or Refractory Multiple Myeloma.” FDA Press Release, 2 July 2025.)

This week’s Oncology Spotlight: Dr. Paul O’Brien’s Unconventional Journey into Medicine (Click here to watch)

Dr. Paul O’Brien’s journey—from food science to clinical medicine across China and Ireland now fuels his mission to combat medical misinformation. On Oncology Spotlight, he discusses resilience from his trainingSquare Artwork, an open‑letter moment, AI in decision‑making, and the fight back against pseudoscience and viral influencers. His story is a powerful call for physicians to reclaim the social‑media narrative.

 

 

 

 

Explore more stories & insights on ONCOassist. Your clinical edge, just a tap away.     

 

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Join the ONCOassist oncology community, the go-to CE‑approved app for oncology professionals worldwide !
  •  Access essential tools like staging systems, toxicity scoring, drug calculators, prognostic scores and NCCN regimens,all in one place .
  • Stay informed with ONCOnews & ONCOvideos featuring expert insights, conference coverage and peer-tested protocols 
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ONCOassist now delivered to 20,000 oncology nurses throughout Europe

by | Feb 2, 2017 | News

Killarney, February 7th 2017: Irish Medical Device Company, Portable Medical Technology, has finalized a partnership with the European Oncology Nursing Society to make it’s flagship product, ONCOassist available to over 20,000 oncology nurses throughout Europe.

ONCOassist is a CE approved decision support application for oncology professionals. It offers oncology nurses and doctors easy access to the decision support tools and information they need via smartphone and tablet application. It is one of the first apps on the market to come with the required regulatory approval enabling it to be used in a hospital setting.

ONCOassist Co-founder Kevin Bambury commenting on the agreement said “ONCOassist’s suite of CE approved decision support tools is used on a daily basis by medical oncologists globally, and through this new agreement with the European Oncology Nursing Society we will expand our reach beyond medical oncologists to oncology nurses. These are very exciting times for ONCOassist.”

Erik Van Muilekom Past President of the European Oncology Nursing Society commented, “ONCOassist is a very useful tool for oncology nurses to use on a daily basis. ONCOassist offers tools like steroid and opiate equivalency converters which are extremely useful, and are now available in a safe, validated format on your smartphone or tablet.”

“There is currently no CE approved app like ONCOassist available for oncology professionals on the market. Decisions are made daily in hospitals around the world using apps that do not have the required regulatory approval. We are delighted to add the 20,000 EONS members to our growing fast growing user base.” said Co-Founder and CEO Eoin O’Carroll.

Welcoming the announcement MEP Sean Kelly stated, “This is an important development for innovative small business in Ireland, given the potential significance of this novel technology, the results of which include saving lives. I look forward to following the results of this innovative technology in the future. It is further evidence of the importance of innovative local companies to the long-term development of the regional economy and I’m delighted to see a partnership with a European Association. This cooperation is the very essence of what EU means and shows the benefit of being a Member of the EU. ”

ONCOassist is based in Killarney, Co. Kerry, it was founded by Kevin Bambury, Eoin O’Carroll and Dr. Richard Bambury who are all graduates of University College Cork. It has been funded by Enterprise Ireland and Chicago based VC Healthbox. It counts 9 out of the top 10 pharmaceutical companies in the world amongst its customers and plans to grow its staff in early 2017.

* * * ENDS * * *

For more information, contact
Kevin Bambury – Portable Medical Technology
+ 353 21 731 9541

kevin@portablemedicaltechnology.com

 

About ONCOassist

ONCOassist is a clinical decision support app for oncology professionals. It contains all the clinical tools oncology professionals need in an easy to use and interactive format. It is offered as a member benefit by the European Society of Medical Oncology and has rapidly growing global userbase. ONCOassist was found in 2012 by Kevin Bambury, Eoin O’Carroll and Dr Richard Bambury.

About European Oncology Nursing Society

The European Oncology Nursing Society is a pan-European organisation dedicated to the support and development of cancer nurses.

Through our individual members and national societies we engage in projects to help nurses develop their skills, network with each other and raise the profile of cancer nursing across Europe. EONS is an independent, not-for-profit, voluntary organisation.