News

Janssen Biotech has submitted a new drug application to the FDA for apalutamide (ARN-509) for the treatment of non-metastatic castration-resistant prostate cancer, the manufacturer of the next-generation oral androgen receptor inhibitor announced today.

Robert Z. Orlowski, MD, PhD, recently discussed 2 cases of patients with multiple myeloma, and the treatment considerations and decisions he would make when treating these patients. Orlowski, chairman, ad interim, director of myeloma, and professor of medicine, The University of Texas MD Anderson Cancer Center, discussed these cases during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Gilteritinib has been granted Fast Track designation by the FDA for adult patients with&nbsp;FLT3 mutation-positive relapsed/refractory acute myeloid leukemia, according to Tokyo-based Astellas Pharma.

According to a multivariate analysis of the Nordic MCL2 and MCL3 trials, the presence of <em>TP53</em> mutations predicts overall survival in younger patients with mantle cell lymphoma.

D Neil Hayes, MD, MPH, has been appointed scientific director of the University of Tennessee Health Science Center Institute for Cancer Research and the Van Vleet Endowed Professor in Medical Oncology in the Department of Medicine.

Howard L. Kaufman, MD, FACS, has been appointed chief medical officer of Replimune Group Inc, a developer of oncolytic immunotherapies for the treatment of cancer. Kaufman has 25 years of leadership in academic oncology and is recognized as one of the leading physician scientists in the oncolytic immunotherapy field.

Internationally recognized cancer geneticist Katherine L. Nathanson, MD, has accepted a new role as deputy director of the Abramson Cancer Center of the University of Pennsylvania. Also at the Abramson Cancer Center, Nathanson is the associate director for population sciences, co-leader of the Cancer Control Program, and chief oncogenomics physician.

Based on findings from the phase III ARIEL3 trial, a supplemental new drug application has been submitted to the FDA for rucaparib as maintenance therapy for patients with recurrent&nbsp;epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Srdan Verstovsek, MD, PhD, recently discussed treatment considerations and decisions in the cases of 2 patients with myeloproliferative neoplasms.&nbsp;Verstovsek,&nbsp;professor of medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, discussed the case scenarios during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

According to an update from the phase II KEYNOTE-052 trial presented at the 2017 Global Congress on Bladder Cancer, pembrolizumab (Keytruda) was safe and provided tumor reduction as well as durable responses as a first-line treatment for patients with&nbsp;cisplatin-ineligible advanced urothelial cancer.

The therapeutic landscape for patients with metastatic urothelial carcinoma is being rapidly altered by clinical trials of immunotherapy, but overall survival could be dramatically improved simply by changing the way quality of life is monitored,&nbsp;according to findings presented at the 2017 Global Congress on Bladder Cancer.

Patients with a history of non-muscle invasive bladder cancer may not have to undergo multiple cytoscopies during routine follow-up, according to data on a new procedure for monitoring RNA indicators of disease recurrence in urine samples.&nbsp;

Michael A. Morse, MD, recently discussed treatment decisions centered around the care of patients with metastatic colorectal cancer. Morse, professor of Medicine, Duke Cancer Institute, explained his treatment decisions in 2 case scenarios during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Internationally recognized surgeon H. Richard Alexander, MD, FACS, has been appointed as the new chief surgical officer at Rutgers Cancer Institute of New Jersey. He will also be a professor of surgery in the Division of Surgical Oncology at the Rutgers Robert Wood Johnson Medical School and a part of the Gastrointestinal Oncology Program at the cancer institute when his position begins this fall, according to a press release from Rutgers Cancer Institute of New Jersey.

A look back at all the FDA news that occurred in the month of September.

The FDA has approved a supplemental new drug application for the use of 180-mg tablets of brigatinib (Alunbrig) for the treatment of patients with non&ndash;small cell lung cancer.

A supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer&nbsp;has been granted a priority review by the FDA.&nbsp;

Abemaciclib (Verzenio) has been approved by the FDA for use as a monotherapy and in a combination regimen for patients with HR-positive/HER2-negative breast cancer. As a monotherapy, the CDK4/6 inhibitor has been approved for patients with&nbsp;metastatic disease who have previously received endocrine therapy and chemotherapy, and as a combination, abemaciclib has been approved for use with fulvestrant for women with advanced&nbsp;breast cancer with disease progression following endocrine therapy.

A supplemental new drug application for lenvatinib as a frontline systemic treatment for patients with advanced hepatocellular carcinoma has been accepted by the FDA, acccording to a statement from Eisai,&nbsp;the company developing the therapy.

In the phase III KEYNOTE-177 trial, investigators are hoping to show that frontline treatment with the PD-1 inhibitor pembrolizumab (Keytruda) can improve progression-free survival compared with standard-of-care chemotherapy in patients with mismatch repair-deficient or microsatellite instability-high colorectal cancer.

Investigators aimed to evaluate the prognostic value of primary tumor location in patients with fully resected colon cancer, as well as its relationship to microsatellite instability-high (MSI-H), <em>RAS</em>, and <em>BRAF</em> mutational status, in a study presented at this year&#39;s World Congress on Gastrointestinal Cancer.

Theodoros N. Teknos, MD, has been chosen as the new president and scientific officer of the University Hospitals Seidman Cancer Center. He will be taking over for the current president Nathan Levitan, MD, who will be retiring this year after 9 years in this position.

Heinz-Josef Lenz, MD, shares his excitement for&nbsp;findings from clinical studies on liquid biopsies, Immunoscore^&reg;, and primary tumor location in colorectal cancer.

Dmitriy Zamarin, MD, PhD, discusses the potential for immunotherapy in the treatment of ovarian cancer.

Nivolumab (Opdivo) was given an accelerated approval by the FDA for the treatment of patients with hepatocellular carcinoma following prior treatment with sorafenib (Nexavar). The approval was granted for patients regardless of their PD-L1 status.&nbsp;

Based on findings from the phase II KEYNOTE-059 study, pembrolizumab has been granted FDA approval for the treatment of patients with PD-L1&ndash;positive recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have received 2 or more&nbsp;lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

The third-generation EGFR inhibitor osimertinib had substantial clinical activity against brain metastases in Asia-Pacific patients with advanced non&ndash;small cell lung cancer harboring the <em>T790M</em> resistance mutation, an updated analysis of a randomized trial showed.

Peter W. T. Pisters, MD, MHCM, has been chosen as the next president of The University of Texas MD Anderson Cancer Center. Pisters has served as president and CEO of University of Health Network (UHN) of Toronto since 2015.

While currently-approved treatments for HCC are typically associated with responses rates of 10% or less, findings presented at the 11th Annual Conference of the ILCA, BLU-554, a potent and highly selective inhibitor of fibroblast growth factor receptor 4 (FGFR4), induced an overall response rate of 16% (95% CI, 6-31) in patients with FGF 19 IHC-positive HCC.

In updated phase III results, lenvatinib continued to be noninferior in overall survival compared with sorafenib for&nbsp;patients with unresectable hepatocellular carcinoma, and achieved significant improvements in progression-free survival, time to progression, and objective response rate compared with sorafenib.