Russ Conroy

Upon acceptance, the FDA will review the resubmitted application between 2 and 6 months for remestemcel-L in pediatric patients.

Developers designed ADI-270 to potentially improve clinical responses in patients with renal cell carcinoma and other CD70-positive tumors.

Developers intend to halt the phase 2/3 SKYSCRAPER-06 trial assessing tiragolumab plus atezolizumab and chemotherapy in nonsquamous NSCLC.

Second interim analysis findings from CARDITUDE-4 show no new safety signals with cilta-cel in relapsed, lenalidomide-refractory multiple myeloma.

Phase 1 data support the application for cosibelimab as a treatment for those with metastatic or locally advanced cutaneous squamous cell carcinoma.

Findings from ELM-1 and ELM-2 support the positive opinion for odronextamab as a treatment for relapsed/refractory follicular lymphoma and DLBCL.

The European Commission is expected to decide on approving epcoritamab in relapsed/refractory follicular lymphoma later in 2024.

HRQOL data from the CheckMate 8HW trial may further support frontline nivolumab/ipilimumab for those with MSI-H or dMMR metastatic colorectal cancer.

The complete response letter for patritumab deruxtecan is based on findings related to a third-party manufacturing site inspection.

Findings from the EPCORE NHL-1 trial support the FDA approval of epcoritamab in relapsed/refractory follicular lymphoma.

More than half of the patients who received mitazalimab plus chemotherapy experienced an unconfirmed objective response in the phase 2 OPTIMIZE-1 study.

Data from FRESCO-2 support the approval of fruquintinib for those with previously treated metastatic colorectal cancer in the European Union.

The European Medicines Agency will begin a centralized review process for subcutaneous nivolumab across multiple solid tumor indications.

Data from CAPItello-291 support the approval of capivasertib/fulvestrant for ER-positive, HER2-negative breast cancer in the European Union.

Capivasertib's safety profile in the CAPItello-290 trial was comparable with prior reports of the agent in advanced triple-negative breast cancer.

The likelihood of response was also higher in patients who received no more than 3 lines of therapy prior to liso-cel in the TRANSCEND CLL 004 trial.

Phase 3 data from the E1910 trial support the FDA approval of blinatumomab in CD19-positive Philadelphia chromosome–negative B-cell precursor ALL.

Data from the DUO-E trial support the FDA approval of durvalumab/chemotherapy for those with primary advanced or recurrent dMMR endometrial cancer.

Those with relapsed/refractory multiple myeloma and lower tumor burden are also more likely to have deeper responses to idecabtagene vicleucel.

Data from a phase 1 trial may support the utility of IBI343 for patients with advanced pancreatic ductal adenocarcinoma.

Investigators of the HEPATORCH trial will present additional data on toripalimab plus bevacizumab in this population at a future academic conference.

Data from the phase 1/2 LIBRETTO-001 trial support the FDA approval of selpercatinib in patients with RET fusion-positive thyroid cancer.

Psychology intervention service may improve gratitude, anxiety, and physical function when a hematopoietic stem cell transplant is conducted vs standard of care.

Phase 1b data on SL-172154 in acute myeloid leukemia will be presented at the 2024 European Hematology Association Congress.

Data from the phase 3 ALINA trial support the approval of alectinib for patients with ALK-positive non–small cell lung cancer in the European Union.

The FDA is expected to decide on approving osimertinib for EGFR-mutated non–small cell lung cancer in the fourth quarter of 2024.

Data show responses lasting for more than 6 months among patients with melanoma who responded to treatment with RP1 plus nivolumab.

The FDA has approved imetelstat (Rytelo) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring at least 4 red blood cell units over 8 weeks who have not responded to, or have lost response to, or are ineligible for erythropoiesis-stimulating agents.

Toxicity in this phase 3 trial was comparable with prior reports of chemotherapy among patients with relapsed/refractory acute myeloid leukemia.

Data support prophylactic treatment with tocilizumab as an option to mitigate the risk of CRS for outpatient dosing of teclistamab.