Sarcomas

The FDA has accepted a BLA for ozekibart in unresectable or metastatic conventional chondrosarcoma, setting a PDUFA goal date of April 14, 2027.

Varegacestat reduced the risk of disease progression or death by 84% vs placebo in progressing desmoid tumors.

Circulating tumor DNA analyses from the phase 1/1b StrateGIST-1 trial also support baseline ctDNA detectability as a potentially prognostic marker in this population.

Abemaciclib markedly improved PFS vs placebo in patients with advanced dedifferentiated liposarcoma.

Bezuclastinib plus sunitinib decreased the risk of progression or death by 50% compared with sunitinib monotherapy in GIST.

The FDA has accepted for review an NDA for bezuclastinib plus sunitinib in imatinib-pretreated GISTs, with a PDUFA date of November 30, 2026.

The PD-1/antiangiogenic combination yielded a 24% ORR and 28-month median PFS, surpassing prior monotherapy benchmarks in refractory chordoma.

The FDA approved T-DXd in early HER2+ breast cancer, adjuvant atezolizumab in MRD+ MIBC, and more.

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The FDA issued a warning about the risk of secondary primary malignancies associated with tazemetostat in epithelioid sarcoma and follicular lymphoma.

R. Lor Randall, MD, FACS, discusses how the introduction of systemic therapies such as pimicotinib in TGCT enables a tumor biology–informed approach to care.

The FDA cleared vepdegestrant in ER+ breast cancer with ESR1 mutations, ODAC voted on key questions in breast and prostate cancer, and more.

An NDA seeking the approval of varegacestat for the treatment of adult patients with desmoid tumors has been submitted to the FDA.

The FDA granted priority review to an I-DXd BLA for extensive-stage small cell lung cancer, a sBLA for zenocutuzumab in NRG1+ cholangiocarcinoma has been submitted to the FDA, and more.

The CSF-1R–targeting monoclonal antibody emactuzumab met key end points in the phase 3 TANGENT study, setting the stage for a BLA submission.

R. Lor Randall, MD, FACS, highlights a recent meta-analysis comparing 2 approaches to surgical management for patients with femoral metastases.

The FDA grants full approval to brexu-cel in mantle cell lymphoma, grants priority review to a lirafugratinib NDA in FGFR2+ pretreated cholangiocarcinoma, and more.

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Cogent Biosciences has submitted an NDA for bezuclastinib for patients with GIST who received prior imatinib.

R. Lor Randall, MD, FACS, highlights primary objectives of, and key takeaways from, the BOOM consensus meeting on PJI management in orthopedic oncology.

R. Lor Randall, MD, FACS, discusses the clinical utility and global variability of DAIR procedures for periprosthetic joint infection in sarcoma.

However, a trend towards OS benefit was observed when treatment with cabozantinib was deferred until after disease progression vs administered upfront.

A drug withdrawal in follicular lymphoma and epithelioid sarcoma, a CRL in lung cancer, and priority review in breast cancer highlight this week's top oncology news.

R. Lor Randall, MD, FACS, discusses results from an analysis of factors associated with local recurrence risk in nonmetastatic Ewing sarcoma.

The FDA indications for tazemetostat in relapsed/refractory follicular lymphoma and epithelioid sarcoma are being voluntarily withdrawn.