News

Nino Balanchivadze, MD, FACP, discusses the rationale for evaluating toxicity based on race in the KEYNOTE-189 study.

Treatment with avasopasem manganese reduced the incidence of radiation-induced, severe esophagitis in patients with lung cancer undergoing chemoradiotherapy, according to AESEOP trial findings.

The positive results from EQUTE informed the doses that will be evaluated in the phase 3 EQUATOR trial of tolizumab versus placebo in combination with corticosteroids as a first-line treatment in patients with acute graft-versus-host disease.

The FDA has accepted a supplemental new drug application for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer and granted it priority review.

Tanya Dorff, MD, discusses the recent findings from a phase 1 clinical trial which explored the use of chimeric antigen receptor T-cell therapy in patients with prostate cancer.

An analysis of the ZUMA-5 and ELARA shows that the 2 CAR T-cell therapies, axicabtagene ciloleucel, and tisagenlecleucel have similar efficacy.

The first patient has been dosed in the phase 1 KN-4802 trial examining the safety, tolerability, and preliminary efficacy of KIN-3248 in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations.

A complete response letter from the FDA has been issued regarding the biologics license application for toripalimab with or without chemotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.

Surface Oncology announced the initiation of new trials of the investigational agent SRF388 in patients with hepatocellular carcinoma and non–small cell lung cancer.

With an FDA orphan drug designation for the treatment of patients with uveal melanoma, darovasertib is being actively investigated in a phase 1/2 clinical trial.

A lower overall risk of neurologic adverse events was seen in patients who received immune checkpoint treatment versus chemotherapy control groups.

The FDA has issued a complete response letter to surufatinib for the treatment of a pancreatic and extra-pancreatic neuroendocrine tumors.

In an interview with Targeted Oncology, John Mascarenhas, MD, discussed emerging therapies in treating myelofibrosis in the frontline setting as well as for those who have received prior ruxolitinib treatment.

Nintedanib plus neoadjuvant chemotherapy did not achieve improvement in pathologic complete response in patients with muscle invasive bladder cancer in the phase 2 NEOBLADE study, but the study provided important survival signals.

Here’s a look back at all the FDA happenings from April 2022.

In an interview with Targeted Oncology, Marc Ladanyi, MD, discussed pooled data of larotrectinib in patients with NTRK fusion-positive cancers and how variability in NTRK gene fusions impacts outcomes.

The combination of ivosidenib and azacitidine revealed a manageable safety profile and quality of life profile in patients with IDH1-mutant acute myeloid leukemia in the phase 3 AGILE study.

Hagop M. Kantarjian, MD, discusses how the treatment landscape of acute lymphocytic leukemia compares to what it used to be.

Results from the phase 3 ARCHES trial confirm the survival benefit of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer.

In an interview with Targeted Oncology™, Hagop M. Kantarjian, MD, discussed the evolution of the acute lymphoblastic leukemia-treatment landscape and how further changes may be soon to come.

Lori A. Leslie, MD, discusses the impact that brexucabtagene autoleucel had on the treatment landscape for patients with relapsed or refractory mantle cell lymphoma.

The FDA has granted fast track designation to SQZ-PBMC-HPV for the treatment of patient with HPV16-positive advanced or metastatic solids tumors, according to an announcement by SQZ Biotechnologies.

Association between itolizumab serum concentrations and clinical response have been identified in patients with acute graft-versus-host disease treated in the phase 1b EQUATE study.

Oncternal Therapeutics announced it would terminate its study of ONCT-216 for patients with Ewing sarcoma and prioritize its phase 3 ZILO-301 study of zilovertamab plus ibrutinib for patients with relapsed/refractory mantle cell lymphoma.

The FDA has accepted the resubmission of an NDA for Pedmark in pediatric patients under the age of 18 with localized, non-metastatic, solid tumors.

Yuliya Mikheeva, MD, PhD, discusses the design of the phase 2 ANAPLAST-NEO study

Results from the melanoma cohort the MATINS trial will be shared at the 18th Congress of the European Association of Dermato-Oncology.

In an interview with Targeted Oncology™, Yonina R. Murciano-Goroff, MD, MSc, DPhil, discussed how MET fusions impact patients with NSCLC and the issue of resistance to targeted therapies that treat MET fusion-positive disease.

The FDA has granted fast track designation to CFI-400945 which has shown encouraging signs of monotherapy activity in patients with acute myeloid leukemia with adverse cytogenetics.

In RATIONALE 306, tislelizumab plus chemotherapy extended overall survival in patients with previously untreated unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.