Russ Conroy

The FDA has set a Prescription Drug User Fee Act date of February 17, 2025, to approve vimseltinib for patients with tenosynovial giant cell tumor.

Data from the phase 3 ADRIATIC trial support the supplemental biologics license application for durvalumab in this limited-stage SCLC population.

Subgroup analysis data from DUO-E support the European approval of durvalumab-based treatment in primary or recurrent endometrial cancer.

Data from the phase 3 MELATORCH study support the supplemental new drug application for frontline toripalimab in unresectable or metastatic melanoma.

Developers anticipate launching a first-in-human phase 1 study assessing ziftomenib/imatinib for those with advanced GISTs in early 2025.

Enrollment will soon begin for the dose-expansion portion of the ongoing phase 1 trial assessing EO-3021 in CLDN18.2-positive tumors.

Investigators are on track to launch part 2 of the phase 1 Deltacel-01 trial in September 2024.

The overall survival data in the phase 3 KeyVibe-008 trial met the prespecified futility criteria.

After a complete response letter and a subsequent biologics license application resubmission, denileukin diftitox has been approved by the FDA.

The SeCore CDx HLA A Sequencing System may help identify patients with advanced synovial sarcoma who are suitable to receive afami-cel.

Combining evorpacept with trastuzumab, ramucirumab, and paclitaxel appeared to be well tolerated among patients enrolled on the phase 2 ASPEN-06 trial.

Phase 3 data from the INDIGO trial support the FDA approval of vorasidenib for select patients with grade 2 astrocytoma or oligodendroglioma.

The safety profile of LP-300 plus chemotherapy in the phase 2 HARMONIC trial was comparable with prior reports of chemotherapy alone.

Investigators assessed alemtuzumab plus UCART22 in relapsed/refractory B-cell acute lymphoblastic leukemia as part of the phase 1 BALLI-01 trial.

Data from SPEARHEAD-1 support the accelerated approval of afamitresgene autoleucel in metastatic or unresectable synovial sarcoma.

Data from the RUBY trial support the expanded approval of dostarlimab plus chemotherapy in patients with advanced/recurrent endometrial cancer.

Phase 1 data may support the potential activity and safety of VCN-01 among pediatric patients with refractory retinoblastoma.

Combining IMNN-001 with chemotherapy also elicited a progression-free survival improvement compared with chemotherapy alone in the OVATION 2 trial.

Data from the PERSEUS trial support the FDA approval of the subcutaneous daratumumab-containing regimen in newly diagnosed multiple myeloma.

Data from ASC4FIRST support the priority review designation for asciminib in Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Data from AMPLIFY show a trend towards improved overall survival with acalabrutinib-based therapy among patients with chronic lymphocytic leukemia.

Shield, the first FDA-approved blood test for CRC screening, may offer convenient screening access for those who are at average risk for the disease.

A user-friendly “nudge” may provide a timely reminder to surgeons to consider the value of sentinel lymph node biopsy in older patients with breast cancer.

The FDA has set a Prescription Drug User Fee Act date of December 28, 2024, for cosibelimab in advanced or metastatic cutaneous squamous cell carcinoma.

Members agreed that perioperative regimen NSCLC trial designs should clarify the contribution of treatment during adjuvant and neoadjuvant therapy.

The agency has set a Prescription Drug User Fee Act date of January 7, 2025, for its decision on approving remestemcel-L in this patient population.

Feedback from a Type C meeting signals the end of preparatory regulatory interactions for the phase 3 TACTI-004 trial’s design in metastatic NSCLC.

Preclinical data support the potential anti-tumor activity and tolerability of a novel FR⍺ topoisomerase I inhibitor in ovarian cancer and NSCLC.

Data from DREAMM-7 and DREAMM-8 support the marketing authorization application for the belantamab mafodotin combinations in multiple myeloma.

Developers plan to submit data from the ARANOTE trial to global regulatory health authorities to expand indications for darolutamide in metastatic HSPC.