News

The combination of carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone reduced the risk of death by 21% compared with lenalidomide and dexamethasone alone for patients with relapsed multiple myeloma following prior treatment with 1 to 3 regimens.

Sacituzumab govitecan (IMMU-132) was well tolerated and demonstrated early and durable responses in heavily pretreated patients with metastatic triple-negative breast cancer (mTNBC), according to the results of a recent phase I/II study published in the <em>Journal of Clinical Oncology</em>.<br /> &nbsp;

Lisa Carey, MD, discusses&nbsp;strategies that can be used to de-escalate treatment in patients with triple-negative breast cancer and the steps toward developing further strategies in this area.

Thomas Flaig, MD, has been named chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panel for Bladder Cancer.

Jorge Garcia, MD, discusses how the field of bladder cancer has transformed with the FDA approval of pembrolizumab, and how oncologists should choose between 5 checkpoint inhibitors now available for the second-line setting and beyond.

Roy S. Herbst, MD, PhD, discusses how the therapeutic paradigm will continue to evolve in the next few years for&nbsp;non&ndash;small cell lung cancer, with an increased emphasis on rational combinations and biomarkers.

David R. Gandara, MD, discusses toxicity management with the combination of&nbsp;dabrafenib and trametinib in&nbsp;non&ndash;small cell lung cancer.

Keith Stewart, MB, ChB, discusses treatment decisions centered around the care of patients with multiple myeloma, including the roles of autologous stem cell transplant and MRD testing.

Andrea Apolo, MD, discusses the pooled analysis of the phase Ib Javelin Solid Tumor study,<span style="font-size:10.8333px"> </span>and the phase I study of cabozantinib, nivolumab, and ipilimumab

Arlene Siefker-Radtke, MD, discusses&nbsp;the current status of biomarker research in bladder cancer, and the impact immunotherapy has had in the field.

Jonathan C. Trent, MD, PhD, recently discussed the treatment considerations he makes when treating patients with gastrointestinal stromal tumors (GIST). Trent discussed his treatment decisions based on 2 case scenarios during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

A supplemental new drug application (sNDA) for alectinib (Alecensa) has been granted a priority review by the FDA for the frontline treatment of patients with <em>ALK</em>-positive locally advanced or metastatic non&ndash;small cell lung cancer (NSCLC), according to Genentech (Roche), the manufacturer of the second-generation&nbsp;ALK inhibitor.

CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, has been approved by the FDA for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), based on an improvement in overall survival (OS) in a phase III study.

A new drug application (NDA) for acalabrutinib has been granted a priority review by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.

A look back at all the FDA news that occurred in July.

Ibrutinib (Imbruvica) has been approved by the FDA for the treatment of adult patients with chronic graft versus host disease (cGVHD) following the failure of 1 or more lines of systemic therapy. The BTK inhibitor is now the first FDA-approved therapy for the treatment of cGVHD.

Acalabrutinib has been granted a breakthrough therapy designation by the FDA for patients with previously-treated mantle cell lymphoma (MCL), according to AstraZeneca, the manufacturer of the highly selective, potent BTK inhibitor.

Enasidenib (Idhifa) has been approved by the FDA as a treatment for patients with relapsed or refractory <em>IDH2</em>-mutated acute myeloid leukemia (AML), based on findings from a phase I/II study. A companion diagnostic, the RealTime IDH2 Assay, was also approved for the detection of the <em>IDH2</em> mutation.

Nivolumab (Opdivo) has been granted an accelerated approval by the FDA for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Rebecca C. Arend, MD, discusses some of the key abstracts presented during ASCO, as we as other key developments in endometrial cancer.

A Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA) for axicabtagene ciloleucel (axi-cel) to treat 3 forms of non-Hodgkin lymphoma (NHL), Kite Pharma has announced.

Diane M. Simeone, MD, is stepping up to lead the new Pancreatic Cancer Center at NYU Langone. She has been a member of NYU Langone since March 2017, and will continue in her role as associate director of translational research at the Perlmutter Cancer Center.

During the 2017 ESMO Congress, to be held September 8-12 in Madrid, Spain, the European Society for Medical Oncology (ESMO) will award 4 oncologists with its distinguished annual awards:

Women with node-positive stage IB-IIB cervical cancer who received systemic chemotherapy post-surgery were at a reduced risk of distant recurrence, according to results from a retrospective study of Japanese women published in the <em>International Journal of Cancer</em>.

Nivolumab (Opdivo) demonstrated clinical activity in women with recurrent/metastatic cervical cancer, and was active to a lesser extent in vaginal and vulvar cancers, according to&nbsp;phase I/II results from CheckMate-358.

Durvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.

The FDA has granted breakthrough therapy designation to venetoclax (Venclexta) for use in combination with low dose cytarabine (LDAC) in treatment-na&iuml;ve elderly patients with acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy, according to Roche, which is codeveloping the BCL-2 inhibitor with AbbVie.

The use of fulvestrant (Faslodex) to treat estrogen receptor (ER)-positive, locally-advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy has been approved by the European Commission (EC).

Progression-free survival (PFS) was not improved with frontline durvalumab (Imfinzi), either in combination with tremelimumab or as a single agent,&nbsp;in patients with stage IV metastatic non&ndash;small cell lung cancer (NSCLC), compared with standard platinum-based chemotherapy.

Elizabeth Plimack, MD, recaps recent advances in bladder cancer and discussed the need for diverse approaches to further improve patient outcomes.