Russ Conroy

Findings from the phase 3 CAPItello-291 trial support the approval of capivasertib/fulvestrant for patients with hormone receptor–positive, HER2-negative breast cancer in Japan.

Data from the phase 3 KEYNOTE-671 trial support the European Commission’s approval of pembrolizumab plus chemotherapy for those with resectable non–small cell lung cancer.

Data from the phase 2 AUGMENT-101 trial support the biologics license application for revumenib in patients with relapsed/refractory KMT2A-rearranged acute leukemia.

Investigators will assess the PRE-ACT tool’s ability to predict adverse effects such as skin and heart damage in a phase 3 trial.

Intracranial disease control with Ivonescimab plus chemotherapy appears encouraging in patients with non–small cell lung cancer and brain metastases.

The agency submits complete response letters based on the enrollment status of confirmatory trials for odronextamab in follicular lymphoma and diffuse large B-cell lymphoma.

The positive opinion is supported by findings from the phase 3 EMBARK trial assessing enzalutamide in patients with biochemically recurrent prostate cancer.

Data from the phase 3 MIRASOL trial support the full FDA approval of mirvetuximab soravtansine for those with folate receptor alpha–positive platinum-resistant ovarian cancer.

Treatment with osimertinib plus chemotherapy also shows a consistent survival benefit across prespecified NSCLC subgroups in the phase 3 FLAURA2 trial.

Data from the phase 3 KarMMa-3 trial support the approval of idecabtagene vicleucel for relapsed/refractory multiple myeloma in the European Union.

The safety of nivolumab plus ipilimumab among those with hepatocellular carcinoma in the CheckMate-9DW trial appears to be comparable with prior reports.

Findings from a phase 2 trial highlight an acceptable adverse effect profile and renal function with stereotactic ablative body radiotherapy in primary renal cell cancer.

Ex vivo generation of CD3-positive, CD56-positive Natural Killer-Like (NKT) with CRX100 was successful in all 7 patients with ovarian cancer in a phase 1 trial.

The regulatory agency sets a Prescription Drug User Fee Act date of August 13, 2024, for denileukin diftitox in relapsed/refractory cutaneous T-cell lymphoma.

Data from the phase 3 PhALLCON trial support the FDA accelerated approval of ponatinib plus chemotherapy in adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

Data from the phase 3 LEAP-001 study support lenvatinib plus pembrolizumab as an active combination for endometrial cancer.

The regulatory agency set an action date of December 28, 2024 for ensartinib as a treatment for those with ALK-positive non–small cell lung cancer.

Members of the committee reviewed findings from the phase 2/3 IMerge trial assessing imetelstat in patients with transfusion-dependent anemia in myelodysplastic syndromes.

Findings highlighted tumor reductions in patients with recurrent glioblastoma who received CART-EGFR-IL13Rα2 cells at 2 dose levels.

Findings from the phase 3 CheckMate 649 trial support nivolumab plus chemotherapy as a standard frontline therapy for patients with gastric, gastroesophageal junction, and esophageal adenocarcinoma.

Targeted imaging and biopsy may accurately identify patients with breast cancer who do not have residual disease, according to Henry Kuerer, MD, PhD, FACS, CMQ.

Treatment with brentuximab vedotin, lenalidomide, and rituximab yielded a progression-free survival benefit in the phase 3 ECHELON-3 trial.

Patient-reported outcomes support the clinical benefits of ide-cel among patients with relapsed/refractory multiple myeloma.

Treatment with simple hysterectomy reduces the incidence of urinary incontinence compared with radical hysterectomy in patients with low-risk cervical cancer.

Investigators plan to reinitiate enrollment of patients with non-Hodgkin lymphoma as part of the phase 1a/1b NX-2127-001 trial.

Reshma Jagsi, MD, DPhil, highlights disparities in hypofractionation, toxicity, and cardiac doses in radiotherapy for Black and Asian patients with breast cancer.

Findings from the INSITE trial support the Medical Imaging Drugs Advisory Committee’s positive opinion on pegulicianine for breast cancer surgery.

Findings from a phase 2 trial support the premise that activating the androgen receptor may elicit antitumor effects in patients with androgen receptor–positive, estrogen receptor–positive, HER2-negative breast cancer.

Developers also announced that they completed enrollment of patients with non–small cell lung cancer in the phase 2 THIO-101 trial.

Treatment with rusfertide may reduce the use of phlebotomy and limit debilitating disease-related symptoms in patients with polycythemia vera based on findings from the phase 2 REVIVE trial.