Jordyn Sava

The new DNA methylation-based PDACatch assay has received a breakthrough device designation from the FDA to detect patients at high-risk for pancreatic adenocarcinoma.

According to findings from an integrated BIM, single treatment with selpercatinib had a little impact on third-party payers’ formulary budgets for patients with RET-altered solid tumors.

Two genetically engineered gamma-delta T-cell therapies, INB-400 and INB-410, have been granted an orphan drug designation from the FDA for numerous types of malignant glioma.

Treatment with lurbinectedin is cost-effective as a second-line treatment for patients with metastatic small cell lung cancer who have had disease progression on or after platinum-based chemotherapy.

Adjuvant chemotherapy did not lead to survival improvements vs standard chemoradiotherapy alone in patients with locally advanced cervical cancer and resulted in more severe adverse events, according to OUTBACK trial data.

In an interview with Targeted Oncology, Adam J. Olszewski, MD, discussed mosunetuzumab and the rationale and findings of this phase 1b/2 study assessing the agent in elderly patients with diffuse large B-cell lymphoma.

Patients with recurrent or metastatic squamous cell carcinoma of the head and neck did not derive an overall response rate benefit with nivolumab and ipilimumab vs nivolumab alone.

The FoundationOne® Liquid CDx has been granted approval by the FDA as a companion diagnostic for mobocertinib for patients with locally advanced or metastatic non–small cell lung cancer harboring an EGFR exon 20 insertion mutation.

Impressive efficacy data and consistent safety data continue to be seen with mirvetuximab soravtansine for the treatment of patients with platinum-resistant ovarian cancer, according to data from the confirmatory MIRASOL trial.

In an interview with Targeted Oncology, Mitchell Smith, MD, PhD, discussed what the findings from the ECOG-ACRIN E1411 trial in patients with mantle cell lymphoma means for the future of the space, and where research is heading.

TPST-1120 shows promising efficacy and safety data in a phase 1b/2 study of the agent among patients with unresectable or metastatic hepatocellular carcinoma.

The TRANSCEND FL and TRANSCEND NHL 001 studies of lisocabtagene maraleucel met its primary end point of overall response rate and secondary end point of complete response rate in patients with follicular lymphoma and B-cell non-Hodgkin lymphoma.

Treatment with TARA-002 at 3 different dose levels was generally well-tolerated, and no dose limiting toxicities were observed among patients with high-grade non-muscle invasive bladder cancer.

Here is a look back at all of the FDA happenings from April 2023.

Findings from the COMMANDS study in which luspatercept showed statistically significant and clinically meaningful improvements for patients with low-risk myelodysplastic syndrome, the FDA has set a target action date of August 28, 2023.

The combination of lenvatinib and pembrolizumab continued to show benefits in efficacy vs chemotherapy among patients with endometrial cancer treated in Study 309/KEYNOTE-775.

In an interview with Targeted Oncology, Ken Kato, MD, PhD, discussed background and findings from the phase 3 CheckMate 648 trial among patients with esophageal squamous cell carcinoma.

The prespecified interim analysis of the RENOTORCH study showed toripalimab plus axitinib improved progression-free survival, overall response rates, and showed no new safety signals among patients with renal cell carcinoma.

This trial of HST-1011 will evaluate the safety, tolerability, pharmacokinetics, harmacodynamics, and preliminary clinical activity of the agent when administered as a monotherapy or in combination with cemiplimab.

The use of DecisionDx-Melanoma to guide better risk-aligned care for patients with cutaneous melanoma who are considered low-risk by staging is supported by study findings.

As we better understand the use of artificial intelligence in oncology, experts can improve outcomes, develop approaches to solve problems, advance the development of treatments that are made available to patients with cancer, and more.

Treatment with ceralasertib with and without olaparib showed promising signals of clinical activity in multiple rare gynecologic cancers, according to findings presented at the European Society for Medical Oncology Gynaecologic Cancers Congress 2023.

A patient treated with the second highest dose level of FHD-609 had a grade 4 adverse event. Enrollment in the study of the agent in patients with synovial sarcoma or SMARCB-1 deleted tumors has been halted.

Promising results from a type C meeting with the FDA has led to a phase 2/3 trial of darovasertib and crizotinib being initiated in 2023 for patients with first-line HLA-A2 negative metastatic uveal melanoma.

Promising efficacy has been seen with the use of immunotherapy for the management of patients with hepatocellular carcinoma, Now, durvalumab and tremelimumab combination therapy is being studied for this patient population listed for a liver transplant.

A phase 1 trial of EPI-7386 will evaluate the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of the agent in combination with apalutamide or abiraterone acetate plus prednisone.

The new Prescription Drug User Fee Act action date for quizartinib for use in patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia has been set to July 24, 2023.

Findings presented at the ASCO April Plenary Series showed that there was a significant event-free survival improvement among patients treated with toripalimab in the phase 3 Neotorch study.

In an interview, Samer A. Srour, MD, MS, reviewed data from the dose-expansion phase of an ongoing phase 1 trial of Orca-Q in the haploidentical stem cell transplant setting for patients with high-risk hematologic malignancies.

In an interview with Targeted Oncology, Mitchell E. Horwitz, MD, discussed the FDA approval of omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant.