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FDA Approves Pirtobrutinib for Previously Untreated CLL/SLL

UCSF’s Kevan Shokat Wins Stephenson Prize for Cancer Breakthrough

FDA Grants Fast Track Designation to TRE-515 Plus KRAS Inhibitors in Pretreated KRAS G12C+ NSCLC

NDA Submission Is Initiated for Zipalertinib Plus Chemotherapy in Frontline EGFR Exon 20 Insertion+ NSCLC

OncLive Weekly News Quiz (10/2/2026): Did You Miss Crucial Lung Cancer, Breast Cancer, MDS, and PTLD Updates?

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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 HCM.

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.

The NMPA has approved of pirtobrutinib in treatment-naive and previously treated CLL/SLL.

Roswell Park Comprehensive Cancer Center recognized members of its clinical, research and healthcare teams during the second annual Excellence Awards.

The top 5 OncLive TV videos of the week cover insights in breast cancer, PV, myeloma, and CLL.

The first MRD data from the phase 3 EXCALIBER-RRMM trial support iberdomide-based triplet therapy as early as first relapse, with PFS follow-up ongoing.

After nearly 7 years of follow-up, daratumumab added to VRd continued to improve PFS, PFS2, and sustained MRD negativity in transplant-eligible myeloma.

The FDA approved lirafugratinib in FGFR2+ cholangiocarcinoma and belzutifan plus lenvatinib in advanced ccRCC, and more.

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

Daiichi Sankyo and Merck withdrew the I-DXd BLA in ES-SCLC after FDA discussions found phase 2 IDeate-Lung01 data insufficient for accelerated approval.

Monthly etentamig significantly improved response and PFS over standard available therapies in the phase 3 CERVINO trial, with low rates of high-grade CRS.

FDA grants priority review to durvalumab plus enfortumab vedotin for cisplatin-ineligible MIBC based on positive phase 3 VOLGA data.

R. Lor Randall, MD, FACS, outlines how AI may affect oncology training, how to properly work alongside AI, and AI-patient conversations.

Results from an early-stage clinical trial found encouraging outcomes in newly diagnosed pancreatic cancer that had spread to distant organs.

Read a refresh of GI cancer FDA news from August 2026, including the approval of a RAS(ON) inhibitor in metastatic pancreatic cancer.

The FDA has approved belzutifan (Welireg) plus lenvatinib (Lenvima) for use in patients with advanced renal cell carcinoma with a clear cell component after PD-1 or PD-L1 inhibition.

R. Lor Randall, MD, FACS, discusses AI in musculoskeletal tumor diagnosis, surgical planning and robotics, and validation of AI tools.

MAPK drugs restore TSHR in aggressive thyroid tumors, helping CAR-T cell therapy see and control solid tumors again.

An FDA advisory committee voted in favor of the benefits of the Galleri MCED test outweighing its risks in patients 50 years of age and older.

Novel approaches to the use of AI in oncology may require discussion and ultimately modification of existing proprietary and regulatory barriers.

Extended follow-up from the phase 1b CAMMA 1 trial showed durable responses across two cevostamab dose levels, supporting selection of a recommended phase 3 regimen.

A MAIC found anito-cel produced response rates similar to those of cilta-cel, with fewer high-grade toxicities, in relapsed/refractory multiple myeloma.

Updated phase 2 LINKER-SMM1 data show single-agent, fixed-duration linvoseltamab produced deep, durable, and MRD-negative responses in high-risk smoldering multiple myeloma.

The FDA has approved lirafugratinib (Lyrfigtu) for the treatment of adult patients with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement.

An IDMC recommended continuing a phase 2 minimal residual disease study of IMNN-001 without modification following a favorable safety review.











































































