News

A biologics license application for SL-401 (tagraxofusp, Elzonris) has been granted a priority review by the FDA as a treatment for patients with blastic plasmacytoid dendritic cell neoplasm,  Stemline Therapeutics, the developer of the novel stemness inhibitor, has announced.

Andre Goy, MD, shares insight on the new array of treatment options for mantle cell lymphoma and how to properly implement them.

Susan M. O’Brien, MD, discusses some of the latest intriguing data in the treatment of CLL, and the growing importance of mutation status.

Joshua Bauml, MD, speaks on the treatment options and considerations he makes when treating patients with non&ndash;small cell lung cancer. Bauml explained his treatment decisions based on 2 case scenarios during a <em>Targeted Oncology </em>live case-based peer perspectives presentation.

The combination of apatinib and oral etoposide showed promising efficacy and a manageable safety profile in patients with platinum-resistant or platinum-refractory ovarian cancer, according to findings from the phase II AEROC trial recently published in <em>The Lancet Oncology</em>.

Karyopharm Therapeutics has announced that a rolling submission of an FDA new drug application has been completed for&nbsp;selinexor as a treatment for patients with penta-refractory multiple myeloma,&nbsp;based on results from part 2 of the phase IIb STORM trial.

Mario Snzol, MD,&nbsp;discusses the latest developments with immunotherapy, which he says is poised to become the standard of care in the treatment of patients with metastatic RCC.

The first patient has been enrolled in the phase III ATHENA trial looking at rucaparib (Rubraca) in combination with nivolumab (Opdivo) in patients with newly diagnosed advanced ovarian cancer, according to Clovis Oncology, the company developing rucaparib.

Mogamulizumab-kpkc&nbsp;(Poteligeo) has been approved by the FDA as a treatment for patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

Hossein Borghaei, DO, MS,&nbsp;discusses results from the subgroup analysis of the ongoing CheckMate-227 trial investigating&nbsp;the combination of nivolumab and ipilimumab in metastatic NSCLC.

Patients with cholangiocarcinoma harboring <em>FGFR2 </em>gene fusions, including patients&nbsp;who had progressed on an FGFR inhibitor, saw a clinically meaningful benefit with TAS-120, according to&nbsp;phase I results presented at the 2018 World Congress on GI Cancer.&nbsp;

The triplet combination of&nbsp;the BRAF inhibitor encorafenib, the MEK inhibitor binimetinib, and the EGFR inhibitor cetuximab has been granted a breakthrough therapy designation by the FDA for the&nbsp;treatment of patients with <em>BRAF</em> V600E&ndash;mutant metastatic colorectal cancer following 1 or 2 prior lines of treatment in the metastatic setting.&nbsp;The designation will expedite the development and review of the novel triplet in this setting.

Patients with relapsed/refractory mantle cell lymphoma (MCL) who experienced progression of disease within 2 years following an upfront chemoimmunotherapy regimen containing high-dose cytarabine were more likely to have worse outcomes than patients who progressed later, according to the results of a retrospective analysis presented at the 2018 European Hematology Association Congress. Alternatively, patients who experienced POD later had an unexpectedly long life expectancy.

Compared with sorafenib (Nexavar) alone, sorafenib in combination with selective internal radiation therapy did not provide a significant survival improvement for patients with&nbsp;advanced hepatocellular carcinoma,&nbsp;according to results from the palliative cohort of the SORAMIC trial presented at the 2018 World Congress on Gastrointestinal Cancer in Barcelona, Spain. However, overall survival improvements were seen with the combination in select subgroup analyses.

Lurbinectedin (PM1183) has been granted orphan drug designation from the FDA for&nbsp;the treatment of patients with small cell lung cancer, according to PharmaMar, the manufacturer of the marine-derived treatment.

Danielle Brander, MD,&nbsp;highlights how recent advances are changing the field of CLL and what it means for physicians and their patients.

The Gene Upshaw Memorial Tahoe Forest Cancer Center has established a cancer care model to address disparities in lung cancer in rural areas. By partnering with the UC Davis Comprehensive Cancer Center and their UC Davis Cancer Care Network, they have been able to address a large issue in cancer care, where 20% of the American population is living in a rural area without access to a National Cancer Institute-designated cancer center.

Guadecitabine failed to improve complete response rate&nbsp;and overall survival&nbsp;in treatment-na&iuml;ve adult patients with AML who are not candidates for intensive induction chemotherapy, missing the coprimary endpoints of the phase III ASTRAL-1, according to&nbsp;Astex Pharmaceuticals and Otsuka Pharmaceutical.

Daniel J. George, MD, professor of medicine and surgery at Duke Cancer Institute, discussed the results from these 2 analyses in this high-risk patient population with RCC compared to metastatic RCC. He also shares his own insights on what to take away from this data.

Treatment with chimeric antigen receptor B-cell maturation antigen T cells induced substantial antitumor activity in patients with heavily treated relapsed/refractory multiple myeloma, according to results from a first-in-human clinical trial.

The combination of&nbsp;lenvatinib (Lenvima) and pembrolizumab (Keytruda) has been granted a breakthrough therapy designation by the FDA as a treatment for patients with advanced and/or metastatic non&ndash;microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after &ge;1 prior systemic therapy.&nbsp;This designation will allow for the expedited development and review of the combination in this setting.

The European Union has approved&nbsp;PF-05280014 (Trazimera), a biosimilar for trastuzumab (Herceptin), to treat&nbsp;patients with HER2 overexpressing metastatic or early breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Quizartinib has been granted a breakthrough therapy designation by the FDA&nbsp;for the treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia.

The FDA issued several approvals in July, including in colorectal cancer, breast cancer, prostate cancer, and acute myeloid leukemia.&nbsp;Here&rsquo;s a look back on the FDA happenings for the month of July 2018.

Adjuvant nivolumab has been approved by the European Commission as a treatment for adult patients with&nbsp;completely resected melanoma with lymph node involvement or metastatic disease, regardless of <em>BRAF</em> mutation status,&nbsp;based on findings from the randomized phase III CheckMate-238 trial.

The approval of pembrolizumab has been recommended by the&nbsp;European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use as a frontline treatment for&nbsp;patients with metastatic nonsquamous non&ndash;small cell lung cancer without <em>EGFR</em> or <em>ALK</em> mutations, regardless of PD-L1 expression. The recommendation is based on data from the&nbsp;phase III KEYNOTE-189 trial.

Iobenguane I-131 has been approved by the FDA for the treatment of&nbsp;adult and pediatric patients aged &ge;12 years with iobenguane scan&ndash;positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy, based on&nbsp;findings from a phase IIb clinical trial that was conducted under the FDA&#39;s special protocol assessment.

RET will join the ever-expanding actionable driver mutations for non&ndash;small cell lung cancer, according to a presentation by Paul Baas, MD, PhD, at the <em>19th Annual</em> International Lung Cancer Congress.

Ovarian cancer expert Kelly McCann, MD, PhD,&nbsp;discusses the process of DNA damage and repair, resistance to PARP&nbsp;inhibitors, and rational combination strategies to overcome resistance.

Magtrace and Sentimag Magnetic Localization System, which uses magnetic detection to identify sentinel lymph nodes for surgical removal in women&nbsp;undergoing mastectomy for breast cancer, has gained approval from the FDA.