News

The FDA has granted an accelerated approval to the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib.

The FDA granted Breakthrough Therapy designation to JNJ-61186372 for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.

After demonstrating promising results that were comparable to targeted therapies in the first 2 cohorts of a phase I clinical trial, the combination of cladribine, cytarabine, granulocyte-colony stimulating factor, and mitoxantrone plus the antibody radiation conjugate lintuzumab-Ac225 in patients with relapsed/refractory acute myeloid leukemia is now being explored in a third cohort.

The addition of tazemetostat to rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone was generally well tolerated and demonstrated early anti-tumor activity in patients with newly diagnosed diffuse large B-cell lymphoma, according to the findings from the phase Ib study.

The combination of elotuzumab plus lenalidomide and dexamethasone did not demonstrate a statistically significant improvement in progression-free survival compared with lenalidomide and dexamethasone alone in newly diagnosed patients with multiple myeloma who are transplant ineligible, missing the primary end point of the phase III ELOQUENT-1 trial.<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Whitney Ducaine, MGC, CGC, CN-BM, discussed the evolution of genetic testing in oncology. She highlighted the importance of having conversations with genetic counselors to help inform the patient on their familial risks as well to help inform treatment decisions.

New data from the RANGE study have found that ramucirumab combined with docetaxel confers a progression-free survival benefit in patients with platinum-refractory advanced urothelial cancer versus placebo and docetaxel in extended follow-up, according to a recent paper in Lancet Oncology.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

The first chimeric antigen receptor T-cell therapy to utilize chlorotoxin to direct T cells to target cancer cells in the brain has been developed at the City of Hope and demonstrated antitumor activity in a preclinical study. Based on these findings, the first-in-human clinical trial has opened enrollment at City of Hope for patients with recurrent or progressive glioblastoma.

In an interview with&nbsp;Targeted Oncology, David S. Hong, MD, discussed the emerging role of multitargeted therapeutics in patients with hematologic malignancies.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a&nbsp;BRCA&nbsp;mutation, according to data from the INFORM trial published in the&nbsp;Journal of Clinical Oncology.

According to results from the phase III DANUBE bladder cancer trial, neither of the co-primary end points of the trial were met. The combination of durvalumab, and tremelimumab did not show an improvement in overall survival in treatment-na&iuml;ve patients with unresectable, stage IV bladder cancer. Also, durvalumab alone failed to show an OS benefit over standard-of-care chemotherapy alone in patients with high PD-L1 expression.

The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.

In an interview with&nbsp;Targeted Oncology, Augusto Villanueva, MD, discussed the role of driver mutations in patients with HCC and how liquid biopsies may help improve the treatment landscape in this patient population.

The combination of fulvestrant and capivasertib prolonged progression-free survival compared with placebo in patients with estrogen receptor-positive breast cancer who were previously treated with aromatase inhibition, according to results from the phase II FAKTION trial, published in&nbsp;The Lancet Oncology.

Changes in the tumor microenvironment following progression on EGFR tyrosine kinase inhibitor therapy suggest a potential for benefit from PD-1/PD-L1 inhibitors in patients with EGFR-positive non&ndash;small cell lung cancer, according to the results of a retrospective study published in Clinical Cancer Research.

In an interview with Targeted Oncology, Alexey V. Danilov, MD, PhD, discussed the ELEVATE-TN trial and other potentially practice-changing BTK inhibitor combinations expected to emerge in chronic lymphocytic leukemia.

In an interview with&nbsp;Targeted Oncology, Alexandra S. Bercow, MD, discussed the results from a retrospective study, which evaluated the role of palliative care in women who died from cervical cancer between 2000 and 2017 at 2 institutions. She also highlighted the benefit of palliative care and why this patient population could benefit more than those with ovarian or endometrial cancers.

In an interview with&nbsp;Targeted Oncology, Shilpa Gupta, MD, discussed the results of the BLASST-1 trial evaluating neoadjuvant nivolumab plus gemcitabine and cisplatin in patients with muscle-invasive bladder cancer undergoing a cystectomy. She highlighted the next steps and key points community oncologists need to know about these data now.

In an interview with&nbsp;Targeted Oncology, Van K. Morris, MD, discussed a pooled analysis of the TRIBE trials to determine how oligometastatic disease status impacts treatment decisions. He also discussed advances in the field, including novel treatments that are emerging for advanced CRC.

The FDA has granted Breakthrough Device designation to GALAD score, a serum biomarker-based device that predicts the probability that patients with chronic liver disease will develop hepatocellular carcinoma.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Both autologous stem cell transplant and allogeneic stem cell transplant can be used as consolidation therapy in patients with mantle cell lymphoma, according to results from a single-center analysis, presented in a poster at the 2020 Transplantation &amp; Cellular Therapy Meetings. However, the benefit of alloSCT is offset by an increased risk of transplant-related mortality and the development of graft-versus-host-disease.

According to findings from a retrospective analysis published in&nbsp;JAMA Oncology,&nbsp;the testosterone-related genetic variant&nbsp;HSD3B1&nbsp;(1245C) is associated with more aggressive disease in patients with metastatic prostate cancer. This is the first clinical trial to validate the relationship between the variant and clinical outcomes, and the results may help physicians determine which patients are more likely to benefit from more aggressive therapy.

The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.

The FDA has granted Fast Track Designation to AL101, an injectable small molecule gamma secretase inhibitor, as treatment of patients with recurrent or metastatic adenoid cystic carcinoma. The designation follows an Orphan Drug Designation granted in May of 2019 for treatment of ACC, Ayala Pharmaceuticals, Inc. announced in a press release.

The triplet combination of selinexor, bortezomib, and dexamethasone demonstrated an improved median progression-free survival rate over the standard regimen of bortezomib and dexamethasone in treating patients with multiple myeloma in the BOSTON trial

The combination of venetoclax plus low-dose cytarabine did not demonstrate a statistically significant improvement in overall survival compared with LDAC plus placebo in patients with acute myeloid leukemia who were ineligible for intensive chemotherapy at the time of a planned analysis, missing the primary end point of the phase III VIALE-C trial.

The FDA has approved the combination of isatuximab-irfc with pomalidomide and dexamethasone as treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.