News

August 2026 FDA oncology updates: iberdomide, zanidatamab, and daraxonrasib win approvals as fast-track designations accelerate targeted pipelines.

A JAK inhibitor with a favorable safety profile demonstrated clinical activity in patients with chronic graft-vs-host disease.

The approval marks the first new agent specifically approved for essential thrombocythemia in the US in nearly 30 years.

ASCO's updated guideline on breast cancer follow-up recommends risk-based surveillance intensity and selective mammography rather than one-size-fits-all follow-up.

The approval is primarily supported by the phase 3 VERIFY study.

Almost one-third of patients became newly eligible for treatment after identification of a previously undetected druggable mutation.

FDA clears IND for ADI-212, an off-the-shelf PSMA-targeted gamma-delta CAR T for metastatic castration-resistant prostate cancer, as phase 1/2 trial readies 2026 enrollment.

During a live event, Casey L. O'Connell, MD, and participants considered how white blood cell count may factor into risk assessment for polycythemia vera.

Shubham Pant, MD, MBBS, explains the significance of the FDA approval of daraxonrasib for mPDAC.

Celcuity seeks FDA expansion for gedatolisib combos in PIK3CA-mutant HR+/HER2– metastatic breast cancer, after VIKTORIA-1 shows longer PFS than alpelisib.

ERAS-0015 is being tested in AURORAS-1, an open-label study enrolling patients with RAS-mutant solid tumors.

The assays are now approved to assess HER2 status in gastric, gastroesophageal junction, and esophageal adenocarcinoma.

The LRRC15-targeting antibody-drug conjugate will be investigated in a first-in-human trial later this year.

The final recommendations were directly shaped by data from 36 published articles.

Phase 2 data show an outpatient fixed-duration combo yields 79% complete responses and 18.6-month PFS in relapsed mantle cell lymphoma.

The approval of daraxonrasib in pancreatic cancer is supported by results from the phase 3 RASolute 302 trial.

FDA issues third CRL for lower-dose dasatinib Dasynoc over manufacturing, not data, as Xspray races to resubmit amid PPI absorption benefits.

An exploratory analysis from the SECOMBIT trial showed differences in outcomes based on thymidine kinase activity in BRAF-mutated melanoma treated with immunotherapy and targeted therapy.

The benefit of daraxonrasib in PDAC may be overstated in RASolute 302 due to informative censoring.

The MODeFIRe-1 trial of MRT-2359 plus apalutamide will focus on AR mutations in metastatic castration-resistant prostate cancer.

In an interview, Surbhi Sidana, MD, explores the significance of iberdomide's FDA approval and how this agent fits into the growing array of novel multiple myeloma therapies.

The FDA approved 2 zanidatamab-based regimens for first-line HER2-positive gastroesophageal adenocarcinoma, based on phase 3 HERIZON-GEA-01 data.

The sBLA for dostarlimab in dMMR/MSI-H rectal cancer is based on the AZUR-1 trial.

In transplant-ineligible or transplant-deferred multiple myeloma, the quadruplet regimen demonstrated sustained benefit in minimal residual disease negativity at nearly 5 years.

Adding radium-223 to cabozantinib did not improve skeletal event-free survival in the phase 2 RADICAL trial of renal cell carcinoma with bone metastases.

Cancer trials enroll more women but rarely compare outcomes by sex, leaving safety gaps and urging equity-focused study design.

Second-line platinum plus pemetrexed produced an 11.5-month median OS and 72% disease control after first-line nivolumab/ipilimumab in pleural mesothelioma.

Experts weigh continuous vs time‑limited CLL therapy, compare acalabrutinib and zanubrutinib, and debate when pirtobrutinib fits first line.