Jordyn Sava

The new VENTANA FOLR1 RxDx Assay has been approved by the FDA and will aid in identifying patients with ovarian cancer who are eligible for targeted treatment with mirvetuximab soravtansine.

A phase 1 trial evaluating 5-aminolevulinic acid and CV01 delivery of ultrasound has begun treating the first 3 of approximately 33 patients with recurrent high-grade glioma.

Mirvetuximab soravtansine has been granted FDA accelerated approval for use in patients with folate receptor alpha-high platinum-resistant ovarian cancer who have received prior treatment with 1 to 3 prior systemic therapies.

Based on OS data from the phase 3 ENGOT-OV16/NOVA trial, the FDA has requested niraparib to have restricted use as a second-line maintenance therapy for patients without germline BRCA mutations.

In an interview with Targeted Oncology, Brian T. Hill, MD, PhD, discussed making treatment decisions for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Based on results from the phase 3 AHOD1331 trial, the FDA has approved brentuximab vedotin in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients with high-risk classical Hodgkin lymphoma.

Part 2 of the NOVA-II phase 2 trial evaluating OQL011 has enrolled the first patient with cancer with VEGFR inhibitor-associated hand-foot skin reaction.

A first-in-human study investigating the safety and immunogenicity of amplivant adjuvant and human papillomavirus type 16 synthetic long peptides demonstrated highly favorable safety and tolerability when used as an intradermal therapeutic vaccine.

In an interview with Targeted Oncology, Tycel Phillips, MD, discussed the many treatment options available and those that are being examined for patients with mantle cell lymphoma in the second-line setting.

In an interview with Targeted Oncology, Ursula A. Matulonis, MD, discussed the pooled analysis of 3 studies which examined single agent mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer.

Treatment with pelareorep plus atezolizumab in patients with advanced/metastatic pancreatic ductal adenocarcinoma led to an overall response rate nearly triple than the average which were previously reported in historical control trials.

Patients with endometrial cancer were more likely to have cardiovascular disease before and after their cancer diagnosis compared with patients without cancer.

Five-year data from the phase 3 KEYNOTE-042 shows that patients with non–small cell lung cancer without EGFR/ALK alterations continue to elicit durable benefit with pembrolizumab monotherapy vs chemotherapy.

The interim analysis of the phase 2 MANTRA-2 trial of milademetan, an MDM2 inhibitor, has demonstrated promising safety and activity in patients with advanced solid tumors. The trial will continue enrolling patients.

In an interview with Targeted Oncology, Susana K. Banerjee, PhD, further discussed the updated results of the MEDIOLA trial and the implications of these findings.

Updated data from the phase 1/2 AUGMENT trial led to a 30% complete remission rate and an overall response rate of 53% with SNDX-5613 when used in patients with relapsed/refractory acute leukemias.

The phase 1 study of lintuzumab-Ac225 combined with the CLAG-M regimen in acute myeloid leukemia demonstrated positive response rates, including an overall survival rate of 53% at 1-year and 32% at 2-years.

A breakthrough therapy designation has been granted by the FDA to elranatamab for relapsed/refractory multiple myeloma.

An abbreviated new drug application was approved by the FDA for leuprolide acetate injection as treatment of patients with advanced prostate cancer.

OTX-2002 has received an orphan drug designation by the FDA for patients with hepatocellular carcinoma. The agent will further be evaluated in the phase 1/2 MYCHELANGELO trial.

In an interview with Targeted Oncology, Edward B. Garon, MD, MS, discussed the results of the phase 3 CANOPY-A study.

Phase 2 trial of trilaciclib administered prior to sacituzumab govitecan-hziy in patients with unresectable, locally advanced, or metastatic triple-negative breast cancer demonstrates encouraging reductions in adverse events.

Based on findings from a phase 2 trial conducted by Memorial Sloan Kettering Cancer Center, the FDA has approved the use of cobimetinib for patients with histiocytic neoplasms.

A phase 1/2 clinical trial evaluating treatment with MRT-2359 in MYC-driven solid tumors has dosed its first patient and looks to improve early signals of clinical activity.

In an interview with Targeted Oncology, Marcin Dzienis, MD, further discussed the phase 4 trial of pembrolizumab plus carboplatin and paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma.

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

A phase 1/2 study of ZN-c3, encorafenib, and cetuximab in patients with BRAF V600E-mutated colorectal cancer will begin, led by Zentalis Pharmaceuticals and Pfizer.

Richard S. Finn, MD, discusses the background on lenvatinib and what led to the development of the LEAP-002 trial.

In the prespecified interim analysis of the COMMANDS trial for low-risk myelodysplastic syndromes, luspatercept had statistically significant and clinically meaningful improvements in red blood cell transfusion independence with no new safety signals.

During a presentation at the 14th Annual International Congress on Myeloproliferative Neoplasms, Naveen Pemmaraju, MD, discussed the current agents being examined for MPNs.