News

The FDA has approved the combination of encorafenib and cetuximab as treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy, according to a press release from Pfizer. 

The addition of pemetrexed and carboplatin chemotherapy to gefitinib doubled progression-free survival and significantly improved overall survival in patients with non&ndash;small cell lung cancer harboring an&nbsp;EGFR&nbsp;mutation compared with gefitinib alone, according to results from a randomized phase III clinical&nbsp;<a>trial</a>.

Paxalisib had a strong signal of clinical efficacy in patients with newly diagnosed glioblastoma, according to the interim analysis of a phase II clinical trial. Survival was compared to previous data on the FDA-approved standard of care, temozolomide, from another study. Although the comparison of different studies is not precise, the magnitude of numerical difference in survival provides evidence that this agent may extend life in patients with glioblastoma, Kazia Therapeutics announced in a press release.&nbsp;

Icotinib, an EGFR tyrosine kinase inhibitor, demonstrated similar efficacy to gefitinib as a treatment of brain metastasis in patients with EGFR-mutated non&ndash;small cell lung cancer, results from a Chinese retrospective study showed.

The FDA has accepted the Biologics License Application for and granted Priority Review to the combination of nivolumab plus ipilimumab with limited chemotherapy as a first-line treatment of patients with metastatic or recurrent non&ndash;small cell lung cancer who have no&nbsp;EGFR&nbsp;or&nbsp;ALK&nbsp;genomic tumor aberrations, according to a press release from Bristol Myers Squibb. The Prescription Drug Free User Act target action date is set as August 6, 2020, and the combination was granted Fast Track designation.

In an interview with Targeted Oncology, James A. Reeves, MD, discussed how targeted therapies are being used presently in lung cancer and the potential of these agents in the future.

Low-dose selinexor will be evaluated in a global randomized clinical trial for hospitalized patients with severe coronavirus disease 2019. This oral selective inhibitor has previously been approved at higher doses by the FDA for the treatment of patients with relapsed/refractory multiple myeloma. The plans to initiate this clinical trial were announced in a press release from Karyopharm Therapeutics Inc, developer of the drug.

Indigenous American ancestry has been linked to an increased incidence of HER2-positive breast cancer, according to the Peruvian Genetics and Genomics of Breast Cancer Study study published in Cancer Research.

The FDA has granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and the other for the combination of balstilimab and zalifrelimab&nbsp;in metastatic cervical cancer.

Sacituzumab govitecan was granted Fast Track designation by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death-ligand 1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, including patients who are platinum ineligible.

A single-institution study from Wuhan, Hubei, showed that admission or recurrent visits to the hospital put patients with cancer at risk for severe adult respiratory syndrome coronavirus 2 infection, and patients with non&ndash;small cell lung cancer over the age of 60 had a higher incidence of coronavirus disease 2019.

In an interview with&nbsp;Targeted Oncology, Maria Reig, MD, PhD, discussed the results from the retrospective analysis of patients with hepatocellular carcinoma treated with nivolumab in the real-life setting in Spain.

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

Treatment with sacituzumab govitecan resulted in &ldquo;compelling evidence of efficacy&rdquo; in patients with metastatic triple-negative breast cancer, leading to an early halt of the phase III ASCENT study, announced Immunomedics in a press release.

Pembrolizumab demonstrated an improvement in progression-free survival in the first-line treatment of patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer, meeting one of the primary end points of the phase III KEYNOTE-177 trial.

The first liquid biopsy assay, a blood test, to detect over 50 types of cancer has been developed and is able to identify in which part of the body that the cancer originated in, based on findings from a prospective multicenter case-control observational trial, the CCGA study published in&nbsp;Annals of Oncology.&nbsp;The test also identified cancer prior to symptoms in most patients, according to a press release.

In an interview with&nbsp;Targeted Oncology, Richard D. Carvajal, MD, discussed the challenges of conducting clinical trials for the treatment of patients with uveal melanoma, as well as the excitement surrounding 2 potential therapies in this space.

The FDA granted approval to luspatercept-aamt as treatment of adult patients with anemia failing an erythropoiesis stimulating agent that requires 2 or more red blood cell units over 8 weeks, that is associated with very low- to intermediate-risk myelodysplastic syndromes,&nbsp;intermediate-risk myelodysplastic syndromes with ring sideroblasts or myelodysplastic/myeloproliferative neoplasm.

Targeted Oncology reviews trending news and videos online for the week of April 3, 2020, including recent updates on the impact of COVID-19 in oncology practice and other FDA news.

Durable remissions were elicited with KTE-X19 in a majority of patients with relapsed or refractory mantle cell lymphoma, according to the updated results from the ZUMA-2 trial published in the New England Journal of Medicine. The treatment did, however, cause serious adverse events that were consistent with known toxicities of chimeric antigen receptor T-cell therapy.

A phase III trial is being planned to explore the use of ruxolitinib (Jakafi) to treat patients with coronavirus disease 2019&ndash;related cytokine storm, according to a press release from Incyte regarding discussions with the FDA.

Despite unprecedented challenges during the month of March 2020 due to the coronavirus disease 2019 pandemic, the FDA continued to push forward with several new approved indications for the treatment of cancer, as well as other designations that could further advance the treatment landscape.

A Biologics License Application has been submitted to the FDA for the potential approval of naxitamab for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

Cabozantinib demonstrated antitumor activity as treatment of patients with advanced Ewing sarcoma and osteosarcoma, warranting further investigation for a potential new therapeutic option for this patient population, according to findings from phase II CABONE study.

The FDA has provided clearance for the initiation of, and immediate enrollment for, a new phase II trial to explore the use of the investigational oncologic agent leronlimab in treating patients with coronavirus disease 2019 who experience mild to moderate respiratory complications.<br /> &nbsp;

The immunotherapeutic vaccine OSE-2101 demonstrated a favorable 12-month survival rate as second- or third-line treatment of patients with HLA-A2-positive advanced non&ndash;small cell lung cancer, meeting the primary end point of overall survival in the phase III Atalante 1 study, according to a press release from the drug developer, OSE Immunotherapeutics, Inc.

Although fludarabine, cyclophosphamide, and rituximab may be efficient in inducing remission for the treatment of patients with Binet A high-risk chronic lymphocytic leukemia, recent data published in&nbsp;Leukemia&nbsp;suggest there is no evidence that this would be better than the current standard of care, which is the &ldquo;watch and wait&rdquo; approach.

A rolling New Drug Application has been submitted for pralsetinib as treatment of patients with RET fusion–positive non–small cell lung cancer, according to a press release from Blueprint Medicines Corporation.

The FDA has granted a priority review to a Biologics License Application for remestemcel-L, an allogeneic cell therapy for the treatment of children with steroid-refractory acute graft-versus-host disease, according to a press release from Mesoblast Limited.

A New Drug Application has been submitted to the FDA for the vascular endothelial growth factor tyrosine kinase inhibitor tivozanib for the treatment of patients with relapsed or refractory renal cell carcinoma, according to a press release from AVEO Oncology.