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September Roundup of FDA Approvals in Oncology: 8 Decisions to Know

FDA Approves Tucatinib Plus Trastuzumab/Pertuzumab as First-Line Maintenance in Advanced HER2+ Breast Cancer

FDA Grants Breakthrough Therapy Designation to Temab-A in Previously Treated c-Met–Expressing Nonsquamous NSCLC

Two Dana-Farber Researchers Receive Prestigious New Innovator Award from the National Institutes of Health

FDA Grants Breakthrough Therapy Designation to Telisotuzumab Adizutecan Plus Bevacizumab in Refractory mCRC

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Pooled data from 3 randomized trials showed ropeginterferon alfa-2b improved responses vs phlebotomy alone but not vs hydroxyurea in polycythemia vera.

Experts break down key multiple myeloma data and trends from the 23rd Annual IMS Meeting.

Firmonertinib did not significantly improve BICR-assessed PFS vs platinum/pemetrexed chemotherapy in first-line EGFR exon 20–mutant NSCLC in FURVENT trial.

Carotuximab plus apalutamide demonstrated longer median progression-free survival than apalutamide alone in an interim phase 2 analysis in mCRPC.

Mayo Clinic researchers led a multicenter study that found dividing radiation into several treatments, known as fractionated stereotactic radiosurgery, reduced the risk of cancer returning after surgery

Ruxolitinib 1.5% cream outperformed placebo vehicle in reducing lesional skin involvement in patients with epidermal or superficially sclerotic cutaneous chronic GVHD.

Lung cancer experts discuss emerging strategies after immunotherapy in advanced squamous NSCLC, including updated PRESERVE-003 data from WCLC 2026.

Most patients treated with talquetamab at a single center would not have qualified for MonumenTAL-1, yet responses were similar regardless of trial eligibility.

Epcoritamab plus R-CHOP reduced the risk of progression or death by 51% vs R-CHOP alone in newly diagnosed DLBCL.

The 19-year veteran of CU Anschutz will be the fourth director in the 41-year history of Colorado’s only NCI-designated comprehensive cancer center.

The estimated 3-year OS rate with botensilimab plus balstilimab was 48% in heavily pretreated recurrent ovarian cancer in the phase 1b C-800-01 trial.

PRV111 produced pathologic complete responses in 21 of 22 patients with noninvasive oral cancer or high-grade dysplasia.

A patient treated at the highest dose level of lira-cel to date had stable disease 90 days after infusion in a phase 1 trial in recurrent ovarian cancer.

A randomized phase 2 trial of berzosertib plus carboplatin in pretreated mCRPC stopped for futility amid fewer responses and more high-grade toxicity than the control arm.

The top 5 OncLive TV videos of the week cover insights in MDS, multiple myeloma, pancreatic cancer, colorectal cancer, and uveal melanoma.

The combination nearly doubled the confirmed response rate in the randomized phase 2 portion of HexAgon-HN, with the greatest benefit in HPV-positive disease.

The FDA approved pirtobrutinib for untreated chronic lymphocytic leukemia, granted priority review to elinzanetant for breast cancer hot flashes, and more.

The 2026 amendment adds 40 new recommendations, including active surveillance, office-based treatment, and chemoablation for select recurrent low-grade disease.

The FDA has approved pirtobrutinib for the treatment of adult patients with previously untreated CLL or SLL harboring no known 17p deletion.

By finding a way to attack the most important human oncogene, KRAS, the UCSF chemical biologist launched a new era in cancer treatment.

TRE-515 earned fast track status in combination with KRAS inhibitors for G12C-mutated NSCLC after anti–PD-(L)1 therapy and platinum-based chemotherapy.

An NDA for zipalertinib in EGFR exon 20 insertion–positive NSCLC is being supported by phase 3 REZILIENT3 data.

Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.

Aglatimagene besadenovec plus EBRT was linked to a 41% lower risk of prostate cancer recurrence or death, alongside durable immune activity.

In case you missed any, read a recap of the episodes of OncLive On Air that aired in September 2026.

Japan approved Optune Pax plus gemcitabine and nab-paclitaxel for unresectable locally advanced pancreatic cancer.

A pilot study represents a milestone toward testing a faster, more powerful, and potentially less-toxic form of radiation therapy for cancer treatment.

Oral azacitidine and cedazuridine met the end point of total cycle azacitidine exposure vs subcutaneous azacitidine in MDS or CMML.

UTRxMYCN M1-14 received orphan drug status for soft tissue sarcoma and RPDD for rhabdomyosarcoma.

Interim data showed that the BCMA-directed CAR T-cell therapy NXC-201 generated complete responses in relapsed/refractory AL amyloidosis.

Estelamari Rodriguez, MD, MPH, discusses the rationale, design, and practice implications of the phase 3 RELATIVITY-1093 trial in nonsquamous NSCLC.

Experts spotlight the variety of breast cancer research being presented at the 2026 ESMO Congress.

The third BLA submission for tabelecleucel follows 2 CRLs and includes updated ALLELE data with additional patients and longer follow-up.

A New England Journal of Medicine report describes complete hepatoblastoma regression in a 3-year-old treated with a novel immunotherapy.

Plinabulin plus docetaxel received fast track designation for pretreated nonsquamous NSCLC without actionable genomic alterations.

FDA Approves Denosumab Biosimilar for Skeletal-Related Events, GCTB, and Hypercalcemia of Malignancy
Denosumab-adet (Degevma) is FDA-approved as an Xgeva biosimilar for SRE prevention in myeloma and bone metastases, giant cell tumor of bone, and hypercalcemia of malignancy.

Faculty convened at an OncLive Scientific Interchange and Workshop to discuss individualized treatment and strategic sequencing in HER2-mutated NSCLC.

Researchers at Wake Forest University School of Medicine identified a protein that may help breast cancer spread to the brain and evade immune defenses.

Benjamin Weinberg, MD, discusses the FDA approval of daraxonrasib, RASolute 302 survival data, safety considerations, and future RAS-targeted therapies in pancreatic cancer.

Half of lenalidomide-refractory patients with 1 to 3 prior lines remained alive and progression free at least 5 years after a single cilta-cel infusion.

Andrew Kuykendall, MD, discusses the FDA approval of rusfertide and how to apply it in clinical practice for polycythemia vera management.

An NDA seeks FDA approval of savolitinib plus osimertinib for EGFR-mutated NSCLC with MET overexpression or amplification after EGFR TKI therapy.

Jason Hafron, MD, discusses the emotional, clinical, and financial burden of false positive cancer screening results and improved risk stratification.

Raajit K. Rampal, MD, PhD, discusses JAK inhibitor choice in cytopenic myelofibrosis, emerging combinations, and anemia-directed agents.

The sNDA for elinzanetant seeks FDA approval for moderate to severe vasomotor symptoms in women receiving endocrine therapy for HR-positive breast cancer.
























































































