Conor Killmurray

In findings from the phase 3 SIERRA trial, Iomab-B-based conditioning for patients with relapsed or refractory acute myeloid leukemia provided significant efficacy and tolerable safety results over the current standard of care.

Early data of the Orca-T cellular therapy showed enough positive results from patients on the therapy to move on to a phase 3 study in this patient population.

Looking at a retrospective analysis of data from a single-center, the use of ruxolitinib decreased non-relapse mortality and improved overall survival for patients with steroid-refractory acute graft-vs-host-disease.

An interim analysis of the phase 3 ALPINE study showed stronger results for patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma on the next generation BTK inhibitor zanubrutinib than standard of care ibrutinib.

In a review of disparities among African American women with breast cancer, researchers found that the make-up of their tumor microenvironment leads to advanced diseases like triple-negative breast cancer.

Findings from the DEBBRAH trial showed that the use of trastuzumab deruxtecan in patients with HER2-positive advanced breast cancer showed promising efficacy for those with brain metastases.

After the results of the phase 2 KarMMa trial showed that idecabtagene vicleucel is a new standard of care in relapsed/refractory multiple myeloma, a real-world analysis continues to show the CAR T-cell therapy could have a wider reach.

Here is a roundup of all the notable FDA news in the oncology space from the month of January.

Findings from the MOMENTUM phase 3 study show that the use of momelotinib significantly impacts patients with myelofibrosis.

The KEYNOTE-991 trial assessing the use of pembrolizumab in combination with enzalutamide and androgen-deprivation therapy has been halted as it failed to reach its primary end points.

A phase 1a/1b, first-in-human study of the novel immunotherapy agent, AB248, has given the agent to its first patient with locally advanced or metastatic solid tumors.

Results from the phase 2 Talem trial, presented at the 2023 Gastrointestinal Cancers Symposium, showed the promising signs of efficacy, anti-tumor activity, and tolerable adverse events when combining blank-microsphere transarterial chemoembolization with lenvatinib and sequential microwave ablation for patients with HCC.

Zanubrutinib has been granted FDA approval for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA has granted the OncobiotaLUNG assay a breakthrough device designation for the early detection of lung cancer.

The FDA has approved the liquid biopsy next-generation sequencing-based test FoundationOne Liquid CDx in companion with entrectinib for patients with non–small cell lung cancer with a ROS1 mutation in their tumor.

In an interview with Targeted Oncology, Jeffrey R. Schriber, MD, discussed the impact of new advancements in the treatment of multiple myeloma, like the use of BiTE cells, on the current and future landscape for this patient population.

In a final analysis of the DREAMM-2 study, results showed the rapid and durable responses of belantamab mafodotin continued in patients with relapsed/refractory multiple myeloma despite ocular toxicities.

Preliminary findings from the KRYSTAL-1 and KRYSTAL-7 trials show the potential for adagrasib in combination with pembrolizumab for patients with non-small cell lung cancer who’s cancer harbors a KRASG12C mutation.

An interim overall survival analysis of the novel therapy sitravatinib combined with nivolumab has cleared the way for a continuation of the phase 3 SAPPHIRE study in patients with advanced non-squamous non–small cell lung cancer.

Results of a study conducted by the Community Oncology Alliance showed significant reductions in screenings at the beginning of the COVID-19 pandemic.

New phase 3 data has led to Genentech removing the US indication of atezolizumab for treatment of patients ineligible for cisplatin chemotherapy with metastatic urothelial carcinoma.

Results from the ARIES trial continue to show the benefit of avelumab monotherapy as a first-line drug for patients with metastatic urothelial cancer with PD-L1 expression.

After an update from the phase 3 DREAMM-3 study the use of belantamab monotherapy for previously treated patients with relapsed or refractory multiple myeloma was pulled from US market authorization by request of the FDA.

An analysis of data from 2002-2015 shows that for patients with mantle cell lymphoma achieving event-free survival after two years may be a prognostic factor for better overall survival outcomes.

Treatment with CUE-101 continued to show promise for patients with head and neck squamous cell carcinoma when combined with pembrolizumab or used as a monotherapy.

Results from a phase 3 study show that the continuous maintenance therapy of enzalutamide reduces the risk of disease progression in certain patients with metastatic castration resistant prostate cancer.

By combining telisotuzumab vedotin with erlotinib for patients with c-MET protein expressing non–small cell lung cancer, researchers saw promising early antitumor activity.

The CAR T-cell therapy tisagenlecleucel showed promising anti-tumor activity in pediatric patients with acute lymphoblastic leukemia.

A pooled analysis of 3 studies showed that there was an extended treatment benefit for patients with FRα positive recurrent ovarian cancer treated with the novel antibody-drug conjugate mirvetuximab soravtansine.

The FDA has released their final guidance for developing drugs and biological products for the treatment of patients with acute myeloid leukemia. This focuses on the end points in which sponsors and clinicians should consider when looking at these new agents.