News

In an interview with Targeted Oncology, Robert Sackstein, MD, discussed ongoing research around the strategy of targeting the sugar coat of cancer cells to potentially aid in cancer treatment, particularly in hematologic malignancies.

The phase 3 COMBI-i trial demonstrated that spartalizumab plus dabrafenib and trametinib has modest efficacy in BRAF V600-positive metastatic melanoma, but no progression-free survival benefit when compared with dabrafenib and trametinib alone.

The FDA has granted a fast track designation to HM43239 for the treatment of patients with relapsed or refractory acute myeloid leukemia whose tumors harbor a FLT3 mutation.

Results of the SEAL study revealed a 30% progression-free survival improvement in patients with advanced, metastatic dedifferentiated liposarcoma who underwent selinexor therapy as well as other efficacy and safety benefits.

Survival rates for patients with different subtypes of early breast cancer who had a pathological complete response after de-escalated 12-week trastuzumab plus pertuzumab with or without weekly paclitaxel are promising.

Fam-trastuzumab deruxtecan-nxki has been approved by the FDA for the treatment of adult patients with unresectable or HER2-positive metastatic breast cancer who have received a prior anti-HER2- based regimen.

Combination of ribociclib plus fulvestrant achieved a median overall survival of 67.6 months in the first-line setting for patients with postmenopausal, hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer.

The FDA has granted priority review to a supplemental biologics license application for durvalumab as treatment of patients with locally advanced or metastatic biliary tract cancer.

The FDA has granted orphan drug designation to AB001 for the treatment of patients with pancreatic cancer and acute myeloid leukemia.

Hagop M. Kantarjian, MD, discusses the introduction of chimeric antigen receptor T cells and their impact on acute lymphoblastic leukemia.

Matthew Galsky, MD, discussed the DS8201-A-U105 trial of T-DXd plus nivolumab in patients with HER2-expressing urothelial cancer.

The FDA has granted breakthrough device designation to Precision-GI, a tool that assists with performing a tumor biopsy.

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.