Russ Conroy

The FDA grants orphan drug designation to investigational G-quadruplex transcription inhibitor QN-302 for pancreatic cancer.

An expert from Natera indicates that post-operative ctDNA level may have strong prognostic and predictive value in patients with resectable colorectal cancer.

LP-284, which now has orphan drug designation from the FDA for mantle cell lymphoma, yielded positive preclinical data at the 2022 American Society of Hematology Annual Meeting and Exposition.

Patients with HER2-positive breast cancer and triple-negative breast cancer may not require breast surgery if a pathological complete response can be identified using image-guided vacuum core biopsy following neoadjuvant systemic therapy.

During the 2022 Society for Urologic Oncology (SUO) Annual Meeting, an expert from the Baylor College of Medicine, discussed how perceptions around the use of testosterone therapy have evolved for patients with metastatic prostate cancer.

In a population of patients with patients with mantle cell lymphoma and follicular lymphoma, zandelisib plus zanubrutinib did not increase the rate or severity of class-related adverse effects.

Data from a meta-analysis suggest that single-fraction stereotactic ablative body radiotherapy could result in a lower incidence of local failure than multifractionated radiation in patients with renal cell carcinoma.

Lenalidomide plus rituximab consolidation therapy prior to bendamustine/rituximab induction did not significantly improve progression-free survival in patients with mantle cell lymphoma in the phase 2 NCTN E1411 trial.

The National Medical Products Administration of China gives approval to mobocertinib for patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations.

Patients with metastatic prostate cancer and dysphagia or difficulty swallowing may benefit from TAVT-45 compared with abiraterone acetate tablets.

Findings from the phase 1b/2 NEXICART-1 study indicated that NXC-201 produced complete responses in 6 evaluable patients with relapsed or refractory AL amyloidosis.

Findings from the phase 3 INTRIGUE trial highlighted improved median progression-free survival in patients with KIT exon–mutated gastrointestinal stromal tumors compared with sunitinib.

Data from the phase 2 FIREFLY-1 trial indicated that tovorafenib yielded responses among pretreated patients with recurrent or progressive pediatric low-grade glioma.

Imetelstat demonstrated clinically meaningful and statistically significant improvement in transfusion independence at 24 weeks among patients with myelodysplastic syndrome in the phase 3 IMerge trial.

Among patients with metastatic pancreatic ductal adenocarcinoma, mitazalimab plus chemotherapy yielded a positive objective response rate in the phase 2 OPTIMIZE-1 trial.

The biologic license application for cosibelimab for patients with metastatic or locally advanced cutaneous squamous cell carcinoma is supported by findings from a phase 1 study.

BT8009 monotherapy, which received fast track designation from the FDA, may be beneficial for adult patients with locally advanced or metastatic urothelial cancer.

The Japanese approval of acalabrutinib for the treatment of patients with treatment-naïve chronic lymphocytic leukemia was supported by data from the phase 3 ELEVATE-TN trial.

The biologic license application for toripalimab plus chemotherapy for the treatment of recurrent or metastatic nasopharyngeal carcinoma is expected to be resubmitted by mid-summer 2023.

The phase 3 NEPTUNE study indicated that durvalumab plus tremelimumab did not reach an amended primary end point of improved overall survival among patients with metastatic non–small cell lung cancer with a blood tumor mutational burden of at least 20 mut/Mb, though the combination did yield a numerical reduction in risk of death.

Data from the phase 1/2 CodeBreaK 100 trial indicated that 84% of patients with KRAS G12C-mutated pancreatic cancer treated with sotorasib experienced disease control.

Topline results from the phase 3 GLOW trial indicated that zolbetuximab plus CAPOX yielded a statistically significant increase in progression-free survival over placebo/CAPOX.

The study’s lead author explained that using rezafungin may avoid some of the negative drug interactions associated with other anti-fungal drugs in patients with cancer.

Findings from the phase 3 NORA study identified a numerically longer median overall survival among patients with platinum-sensitive recurrent ovarian cancer treated with maintenance niraparib regardless of BRCA mutation status.

Data from the phase 3 PEARL trial indicated that durvalumab yielded a clinically significant improvement in overall survival but did not meet statistical significance among patients with stage IV non–small cell lung cancer with high PD-L1 expression.

Olaparib in combination with abiraterone and prednisone or prednisolone alone has been approved as treatment for metastatic castration-resistant prostate cancer in the European Union.

The FDA granted breakthrough therapy designation to adagrasib plus cetuximab for patients with KRAS G12C–mutated advanced colorectal cancer based on findings from the phase 1b cohort of the KRYSTAL-1 trial.

The FDA has approved the FoundationOne Liquid CDx as a companion diagnostic for identifying patients with non-small cell lung cancer harboring EGFR mutations who may benefit from treatment with specific tyrosine kinase inhibitors.

The FDA has set the Prescription Drug User Fee Act date for April 21, 2023 for each supplemental biologics license application of enfortumab vedotin-ejfv and pembrolizumab in urothelial carcinoma.

The FDA has approved the Agilent Resolution ctDx FIRST assay for identifying patients with KRAS G12C–mutated non–small cell lung cancer who may benefit from adagrasib.