Chris Ryan

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.

IMM2510 plus chemotherapy generated responses in the first-line treatment of advanced non–small cell lung cancer.

The FDA has granted fast track designation to ateganosine for non–small cell lung cancer.

DZD8586 was active with a tolerable safety profile in heavily pretreated, relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Results of an observational study showed that immunohistochemistry could act as a biomarker for the early detection of TP53‐mutant MDS or AML.

The EMA’s CHMP recommended the approval of vimseltinib for symptomatic tenosynovial giant cell tumor.

Perioperative tislelizumab received a positive CHMP opinion for resectable non–small cell lung cancer at high risk of recurrence.

The combination of sonrotoclax and zanubrutinib produced deep and durable responses in relapsed/refractory mantle cell lymphoma.

The FDA has approved a generic version of ibrutinib tablets for B-cell malignancies.

The FDA has granted breakthrough therapy designation to elironrasib for KRAS G12C–mutated advanced NSCLC previously treated with chemotherapy and immunotherapy.

The novel bispecific antibody TQB2930 plus chemotherapy elicited responses in heavily pretreated HER2-positive breast cancer.

The combination of talazoparib and tazemetostat was safe and led to PSA reductions in certain patients with metastatic castration-resistant prostate cancer.

The FDA granted fast track designation to DB-1310 for patients with pretreated, advanced non–small cell lung cancer harboring select EGFR mutations.

The FDA has issued a complete response letter for RP1 plus nivolumab for advanced melanoma after a PD-1 inhibitor–containing regimen.

The European Commission approved obe-cel for adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Osimertinib plus chemotherapy improved overall survival in the first-line treatment of advanced non–small cell lung cancer harboring EGFR mutations.

JSKN003 demonstrated tolerability and antitumor activity in heavily pretreated HER2-positive breast cancer.

The FDA issued a CRL to the application for glofitamab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

The FDA granted breakthrough therapy designation to first-line trastuzumab deruxtecan plus pertuzumab in HER2-positive metastatic breast cancer.

Justin T. Jordan, MD, MPH, FAAN, discusses the implications of the FDA approval of mirdametinib for adult NF1-associated plexiform neurofibromas.

Safety and efficacy data for elotuzumab support its further investigation in the treatment of myelofibrosis.

Certain factors were associated with sustained remission with obe-cel in acute lymphoblastic leukemia.

The FDA received a BLA resubmission for tabelecleucel in EBV-positive post-transplant lymphoproliferative disease.

Pasritamig was safe and produced durable responses in heavily pretreated metastatic castration-resistant prostate cancer.