Jordyn Sava

Data from the phase 2 CADENZA trial revealed front-line pivekimab sunirine to demonstrate clinical activity in patients with blastic plasmacytoid dendritic cell neoplasm.

Here is a look back at the FDA happenings from the month of August 2022.

Top-line data from the SELECT trial of vopratelimab plus pimivalimab vs pimivalimab alone missed its primary end point of mean tumor change but showed encouraging trends for secondary end points.

In an interview with Targeted Oncology following the tweet chat, Warren Swegal, MD, discussed the key takeaways from the discussion, including his thoughts on the case and what he hopes will be addressed in the future of the thyroid cancer space.

In an interview with Targeted Oncology, Chen Yuan, MD, further discussed the research on the age-dependent associations and risks for patients with pancreatic cancer.

The FDA has cleared TakeAim Leukemia study to continue enrolling emavusertib with or without azacytidine and venetoclax in patients with acute myeloid leukemia or myelodysplastic syndrome.

The phase 3 MAGNOLIA study has begun enrolling patients to examine abelacimab for the treatment of thrombosis associated with cancer.

William J. Gradishar, MD, discusses the most recent evolutions in the management of patients with advanced breast cancer.

An investigational new drug application has been accepted by the FDA allowing for the start of a phase 1 trial to evaluate the tolerability of CNTY-101 in patients with relapsed or refractory CD19 positive B-cell malignancies

Findings from the phase 3 DETERMINATION trial show lenalidomide plus bortezomib, dexamethasone, and autologous stem cell transplantation to improve progression-free survival in patients with multiple myeloma.

Meaningful progression-free survival and safety elicited with isatuximab plus pomalidomide and dexamethasone treatment in real-world multiple myeloma population.

Approval has been granted by the FDA to pemigatinib for the treatment of patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement based on the phase 2 FIGHT-203 trial.

A biologics license application for lifileucel has been initiated by the FDA following positive findings of the phase 2 C-144-01 trial in advanced melanoma.

Following promising preclinical data, the phase 1 IMproveMF trial in myelofibrosis doses its first patient with imetelstat and ruxolitinib.

CE label expansion has been given to the VENTANA PD-L1 assay for patients with non-small cell lung cancer as a companion diagnostic for atezolizumab.

The CRC-PREVENT trial examining the ColonoSight test in colorectal cancer and advanced adenomas has completed enrollment with a diverse patient population.

Promising responses including a positive safety profile were seen with teclistamab when used as treatment for patients with relapsed/refractory multiple myeloma.

Due to suspected cases of fatal differentiation syndrome in a clinical trial, the FDA has placed a full clinical hold on the study of FHD-286 in acute myeloid leukemia and myelodysplastic syndrome.

A phase 1b/2 clinical trial aims to evaluate the safety of lanraplenib plus gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia.

Final overall survival results of the phase 2 ELOQUENT-3 trial reveal benefit with elotuzumab plus pomalidomide, and dexamethasone in patients with relapsed/refractory multiple myeloma.

Several priority areas need to be examined in future research to improve the quality of clinical guidelines to address when and how to monitor pediatric hematopoietic stem cell transplant survivors.

The FDA has approved a label expansion for the VENTANA MMR RxDx panel to identify patients with dMMR solid tumors and pMMR endometrial cancer who are eligible for treatment with pembrolizumab.

Earlier treatment in patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma may offer better survival benefit compared with chemotherapy or best supportive care.

Based on findings from the interim phase 1 portion of a trial examining ART4215 in combination with talazoparib in BRCA deficient breast cancer, a phase 2 portion will be initiated.

Findings from the phase 2 PILOT study reveal lisocabtagene maraleucel to provide benefit as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation.

The phase 3 KEYNOTE-921 trial did not meet its coprimary end points of overall survival and radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer.

The phase 3 RATIONALE 301 trial of tislelizumab in patients with unresectable hepatocellular carcinoma has met its primary end point of non-inferior overall survival.

The combination of fruquintinib and best supportive care improved overall survival vs BSC alone in patients with metastatic colorectal cancer.

With a median progression-free survival of 46.2 months in the RVD-alone group and 67.5 months in the transplantation group, lenalidomide, bortezomib, and dexamethasone plus autologous stem cell transplantation extends overall survival in patients with newly diagnosed multiple myeloma.

The combination of paxalisib and radiotherapy exhibited complete or partial responses in all patients with brain metastases, according to interim data from an ongoing phase I clinical trial.