News

According to a presentation during the 2018 International Liver Cancer Association Annual Conference, the rapid development of novel therapies for patients with unresectable hepatocellular carcinoma has dramatically expanded systemic treatment options over the last 2 years. This has created a need for new sequencing strategies in HCC. 

Fabio Piscaglia, MD, discusses the updated 2018 European Association for the Study of the Liver clinical guidelines, which were presented during the 12th International Liver Cancer Association Annual Conference in London, United Kingdom.

Moxetumomab pasudotox has been approved by the FDA for the treatment of adult patients with relapsed or refractory hairy cell leukemia who have received at least 2 prior lines of therapy, including treatment with a purine nucleoside analog.

Minimal residual disease data from the phase III MURANO trial has been added to the label for venetoclax (Venclexta) by the FDA for its approved use in combination with rituximab (Rituxan) for previously-treated patients with chronic lymphocytic leukemia.

In an interview with&nbsp;<em>Targeted Oncology</em>, Abou-Alfa discussed those clinical trials and other investigated treatment options for patients with hepatocellular carcinoma. He also highlighted his hopes for the future of this disease.

Combining cladribine and low-dose cytarabine alternating with decitabine (Dacogen) resulted in high response rates and improved survival compared with currently established low-intensity therapies for patients with acute myeloid leukemia who are older than 60, according to results newly published in <em>Lancet Haematology.</em>

A&nbsp;supplemental biologics license application for pembrolizumab (Keytruda) has been granted a priority review designation by the FDA for the frontline treatment of patients&nbsp;with locally advanced or metastatic nonsquamous or squamous non&ndash;small cell lung cancer with a PD-L1 expression level of &ge;1% and no <em>EGFR</em> or <em>ALK</em> genomic tumor aberrations.

Progression-free survival was significantly improved in treatment-na&iuml;ve patients with advanced renal cell carcinoma by combining&nbsp;the PD-L1 inhibitor avelumab (Bavencio) with the VEGF inhibitor axitinib (Inlyta) compared with sunitinib, according to findings from the phase III JAVELIN Renal 101 study.

According to findings from the&nbsp;phase IIIb CONSIGN trial, now published in <em>The Oncologist</em>, safety and efficacy findings&nbsp;for regorafenib in patients with previously treated metastatic colorectal cancer were consistent with previous phase III results.

Padmanee Sharma, MD, PhD,&nbsp;shares insight on the current state of immunotherapy in the treatment of patients with GU cancers.

Bijal D. Shah, MD,&nbsp; discusses the challenge of treating this highly heterogeneous disease, how to choose the optimal treatment regimen, and the ongoing role of BTK inhibitors.

Paolo A. Ascierto, MD, discusses&nbsp;results from the COLUMBUS trial and sheds light on how physicians can use these findings when choosing treatments for their patients. He also shared his insights on the CheckMate 238 trial investigating nivolumab in the adjuvant setting.

The FDA now requires use of an approved companion diagnostic test to determine PD-L1 levels in the tumor tissue of cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer prescribed treatment with pembrolizumab (Keytruda) or atezolizumab (Tecentriq).

Frontline pembrolizumab (Keytruda) has been approved by the European Commission for&nbsp;use in combination with standard chemotherapy as a treatment for patients with metastatic nonsquamous non&ndash;small cell lung cancer without <em>EGFR</em>&nbsp;or <em>ALK</em> mutations. The approval is&nbsp;based on results from the phase III KEYNOTE-189 trial.

Tanios Bekaii-Saab, MD,&nbsp;shares his insights on the results from the ReDOS trial, as well as the IMblaze370 trial for patients with mCRC

In an interview with&nbsp;<em>Targeted Oncology</em>, Simon Rule, MD, PhD, professor of Hematology at Plymouth University Medical School, United Kingdom, discusses the current treatment paradigm for MCL, as well as the potential use of BTK inhibitors for the treatment of this patient population.

Cathy Eng, MD, discusses recent data that could shape the treatment landscape for several GI cancers.

The review period for a supplemental biologics license application seeking the approval of atezolizumab (Tecentriq) for use in combination with bevacizumab (Avastin), carboplatin, and paclitaxel or the first-line treatment of patients with metastatic nonsquamous non&ndash;small cell lung cancer has been extended by the FDA.

Keith T. Flaherty, MD, discusses results for the combination of encorafenib and binimetinib in patients with&nbsp;<em>BRAF</em>-mutated melanoma investigated in the COLUMBUS trial. He also highlights the potential implications and next steps.

LOXO-292 has been granted a breakthrough therapy designation by the FDA for the treatment of&nbsp;patients with <em>RET</em> fusion&ndash;positive non&ndash;small cell lung cancer or <em>RET</em>-mutant medullary thyroid cancer.

Manish A. Shah, MD,&nbsp;discusses key details of the KEYNOTE-180 trial, as well as results from the BRIGHTER study. He also shared his insights on the unanswered questions that still need to be addressed in the field.

Leading lung cancer researcher and clinician, Vassiliki A. Papadimitrakopoulou, MD, is the recipient of the 2018 Addario Lectureship Award presented by The Bonnie J. Addario Lung Cancer Foundation for her groundbreaking clinical research in immunotherapy.

<div>The combination of the MEK inhibitor refametinib and sorafenib&nbsp;improved overall survival and overall response rate&nbsp;compared with refametinib alone in patients with <em>RAS</em>-mutated hepatocellular carcinoma, according to an analysis of a pair of phase II proof-of-concept studies.</div>

According to findings from the CheckMate-032 trial, clinically meaningful and durable antitumor activity was found with nivolumab (Opdivo) alone and nivolumab plus ipilimumab in heavily-pretreated patients with esophagogastric cancer.

A supplemental biologics license application for pembrolizumab (Keytruda) has been granted a priority review by the FDA&nbsp;for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The application is seeking accelerated approval for the PD-1 inhibitor, manufactured by Merck.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;August 2018, including several new approvals, a priority review, breakthrough therapy designations, and more in a variety of cancer types.

An expert in hematologic malignancies, Harry Erba, MD, PhD, has been appointed director of both the Leukemia Program and Phase I Development in Hematologic Malignancies in the Division of Hematologic Malignancies and Cellular Therapy in the Department of Medicine at the Duke Cancer Institute in Durham, North Carolina.

Benjamin P. Levy, MD, discusses his clinical considerations for the management of non

In an interview with <em>Targeted Oncology</em>&nbsp;prior to the FDA approval of nivolumab in SCLC, Paul A. Bunn Jr, MD, discusses the potential agents for the treatment of SCLC, the challenges in treating this patient population, and the ongoing search for biomarkers to guide treatment decisions.

Francisco J. Esteva, MD, PhD,&nbsp;discusses the current data surrounding CT-P6 demonstrating its potential as a biosimilar for trastuzumab in the United States.