Chris Ryan

The VENTANA HER2 (4B5) test earned CE-IVDR approval in Europe to assess HER2 status in metastatic breast cancer and biliary tract cancer.

Findings from a meta-analysis associated asciminib with improved efficacy and safety vs other TKIs in chronic myeloid leukemia.

The first part of a PMA seeking the approval of PredicineCARE as a companion diagnostic in bladder cancer was submitted to the FDA.

The development of ZW171 for gynecologic, thoracic, and GI cancers is being discontinued.

TT125-802 has received FDA fast track designations in EGFR+ and KRAS G12C+ advanced NSCLC.

Annamycin plus cytarabine produced a potential overall survival benefit in acute myeloid leukemia.

Palbociclib hit the primary end point of disease control in a phase 2 study of patients with advanced chordoma harboring p16 and/or CDKN2A loss.

The European Commission approved neoadjuvant tislelizumab plus chemotherapy, followed by adjuvant tislelizumab, for resectable non–small cell lung cancer.

Ivonescimab plus chemotherapy improved overall survival in previously treated, advanced non–small cell lung cancer harboring EGFR mutations.

Venetoclax plus obinutuzumab generated safe and efficacious real-world outcomes in first-line CLL with comorbidities.

Krystal Biotech will prioritize the development of KB707 as an inhaled formulation for non–small cell lung cancer.

Alpha1H met all primary and secondary end points in a phase 2 study in non–muscle-invasive bladder cancer.

Magrolimab plus nivolumab and FOLFOX with bevacizumab or cetuximab yielded responses in advanced/recurrent colorectal cancer.

The European Commission approved nirogacestat for the treatment of progressing desmoid tumors requiring systemic treatment.

Adjuvant atezolizumab improved DFS and OS after a positive Signatera MRD test in muscle-invasive bladder cancer.

Bortezomib plus mitoxantrone hydrochloride liposome and dexamethasone produced responses with manageable safety in relapsed/refractory myeloma

The development of SGR-2921 in relapsed/refractory AML and higher-risk MDS was discontinued followed by 2 patient deaths.

Retrospective data showed CAR T-cell therapy is feasible in patients with aggressive lymphomas and active autoimmune diseases.

Treatment with the combination of anlotinib and toripalimab produced durable efficacy in soft tissue sarcoma and bone sarcoma.

Real-world tucatinib-based regimens were effective in different lines for HER2-positive metastatic breast cancer, including after trastuzumab deruxtecan.

Real-world data supported the clinical effectiveness of first-line palbociclib plus endocrine therapy in HR-positive, HER2-negative breast cancer.

The FDA accepted an NDA for vepdegestrant in ER-positive, HER2-negative advanced breast cancer harboring ESR1 mutations after prior endocrine therapy.

The FDA granted orphan drug designation to SAR446523 for relapsed/refractory multiple myeloma.

The FDA granted accelerated approval to zongertinib for pretreated, unresectable or metastatic non–small cell lung cancer harboring HER2 mutations.

The FDA granted regenerative medicine advanced therapy designation to GLPG5101 for relapsed/refractory mantle cell lymphoma.

A dose-expansion cohort will further evaluate SENTI-202 in relapsed/refractory acute myeloid leukemia.

The FDA provided feedback on next steps of development for eftilagimod alfa in PD-L1–negative recurrent/metastatic head and neck squamous cell carcinoma.

Neoadjuvant pembrolizumab could represent an avenue for organ preservation in nonmetastatic, unresectable, dMMR colorectal cancer.

The FDA granted priority review to a supplemental biologics license application for lisocabtagene maraleucel in relapsed/refractory marginal zone lymphoma.

A retrospective study showed immune checkpoint inhibitors may be an option in appropriate indications for patients with neurologic autoimmune disorders.