News

In the phase I/II TRANSCEND CLL 004 study, chimeric antigen receptor T-cell therapy lisocabtagene maraleucel led to undetectable minimal residual disease in patients with relapsed/refractory chronic lymphocytic leukemia.

In an interview with <em>Targeted Oncology</em>, Kieron Dunleavy, MD, examined the role of liquid biopsy throughout the course of disease for all lymphomas, and specifically for patients with mantle cell lymphoma, and how its role may change in the future.

The combination of bempegaldesleukin and nivolumab was granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of patients with previously untreated unresectable or metastatic melanoma.

With 5 tyrosine kinase inhibitors approved for the treatment of patients with hepatocellular carcinoma, the next step for research in this treatment paradigm is focused on identifying the appropriate sequence of these agents.

Ribociclib in combination with fulvestrant demonstrated a statistically significant improvement in overall survival in postmenopausal women with hormone receptor&ndash;positive, HER2-negative advanced or metastatic breast cancer, according to interim results from the phase III MONALEESA-3 trial.

Olaparib improved progression-free survival compared to placebo in patients with&nbsp;<em>BRCA</em>-mutant metastatic pancreatic cancer, based on data from the phase III POLO trial presented at the 2019 ASCO Annual Meeting.

Take a look back on the FDA happenings, including approvals, fast track designations, priority reviews, and more from the month of July 2019.

Kieron Dunleavy, MD, discussed current approaches to treating patients with MCL, highlighting peer discussions on the subject and information about the ZUMA-2 trial, in an interview with&nbsp;<em>Targeted Oncology</em>.

Nivolumab demonstrated long-term survival benefit in heavily pretreated patients with advanced melanoma, renal cell carcinoma, and non&ndash;small cell lung cancer, according to an analysis of 5-year results from the CA209-003 trial. The analysis also identified favorable and adverse factors associated with survival that could inform future use of nivolumab.&nbsp;

The FDA has approved pembrolizumab monotherapy as a treatment for patients with recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1, as determined by an FDA-approved test, and who have disease progression after &ge;1 prior systemic regimen.&nbsp;

Darolutamide has been approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer.&nbsp;

During an interview with&nbsp;<em>Targeted Oncology</em>, Aditya Bardia, MD, MPH, discussed the current role of both liquid biopsy and NGS in breast cancer management, improvements that are needed, and research that shows a promising future.

EGFR tyrosine kinase inhibitors have remained the frontline standard of care for patients with&nbsp;<em>EGFR-</em>positive non&ndash;small cell lung cancer. The most commonly used EGFR TKI in the frontline setting in the United States is&nbsp;osimertinib, Heather Wakelee, MD, said during a presentation at the 2019 International Lung Cnacer Congress.

The combination of abemaciclib and fulvestrant has demonstrated a statistically significant improvement in overall survival compared with fulvestrant and placebo in women with HR&ndash;positive, HER2-negative advanced or metastatic breast cancer who have previously received endocrine therapy, according to updated interim results from the phase III MONARCH 2 trial.

Srdan Verstovsek, MD, PhD, discussed the treatment decisions he makes when treating a patient with a myeloproliferative neoplasm.

The American Oncology Network, LLC will be acquiring a new practice from Ohio in August.

Vivek Subbiah, MD,&nbsp;discussed the activity and tolerability of BLU-667 in patients with advanced&nbsp;<em>RET</em>-altered MTC and PTC. He also discussed the next steps planned for this ongoing trial and how this agent can impact the treatment landscape of patients with&nbsp;<em>RET</em>-altered thyroid cancers.

Carey K. Anders, MD, spoke with <em>Targeted Oncology</em> about treatment options emerging to improve outcomes for patients with metastatic breast cancer and secondary brain metastases.

A theranostic approach to radioactive iodine therapy in thyroid cancer has become the standard of care and represents a more precise means of managing patients based on disease-specific features, according to a presentation on differentiated thyroid cancer management at the Society of Nuclear Medicine and Molecular Imaging 2019 Annual Meeting, held June 22-25, 2019, in Anaheim, California.

The combination of pembrolizumab with chemotherapy demonstrated a benefit in terms of pathological complete response when used as neoadjuvant therapy compared with chemotherapy alone in patients with triple-negative breast cancer, according to interim results of the pivotal phase III KEYNOTE-522 trial.

The approval of TAS-102 has been backed by the&nbsp;European Medicines Agency&#39;s Committee for Medicinal Products for Human Use for the treatment of&nbsp;adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, in those previously treated with at least 2 prior systemic therapy regimens for advanced disease.

In an interview with&nbsp;Targeted Oncology, Naveen Pemmaraju, MD, an associate professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, discussed the safety of SL-401 as a treatment in patients with MF following relapse or intolerance to JAK inhibition, based on data from an ongoing phase I/II clinical trial. He highlighted other research that also appear promising for this subgroup of patients with a poor prognosis.

Laura Dawson, MD, FRCPC, FASTRO, has been selected as the president-elect of the American Society for Radiation Oncology and will begin her term at the society&rsquo;s 61st Annual Meeting, which is being held in Chicago, Illinois on September 15-18.

In an interview with&nbsp;Targeted Oncology, Rodabe N. Amaria, MD, discussed the guidelines and recommendations outlined by the INMC. She also highlighted the importance of genomic testing in the neoadjuvant setting of melanoma.&nbsp;

Nivolumab in combination with a low dose of ipilimumab demonstrated an improvement in overall survival compared with chemotherapy in patients with newly diagnosed non&ndash;small cell lung cancer whose tumors have PD-L1 expression&nbsp;&ge;1%.

In an interview with&nbsp;Targeted Oncology, Richard M. Stone, MD, discussed the biggest controversies across a number of patient populations in AML. He also highlighted some areas of research he finds particularly exciting for the treatment of patients with AML.

A new drug application for tazemetostat, an EZH2 inhibitor,&nbsp;has been granted a priority review by the FDA for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery&nbsp;based on data from the&nbsp;epithelioid sarcoma cohort of a phase II trial.

In an interview with&nbsp;Targeted Oncology, Arlene Siefker-Radtke, MD, discussed the results from this trial that led to the approval of erdafitinib in patients with locally advanced or metastatic bladder cancer who have progressed on platinum-based chemotherapy. She also explained the impact of this approval in this patient population and next steps planned for this agent.

In an interview with <em>Targeted Oncology</em>, Peter Martin, MD, assistant professor of medicine, Division of Hematology/Oncology, Weil Cornell Medicine, recounts physician crossfire discussions related to frontline MCL treatment and provides his own expert opinion on the subject.

The FDA has granted an orphan drug designation to MB-102, a CD123-directed CAR T-cell therapy, for the treatment of patients with acute myeloid leukemia.