News

A round-up of all the FDA activity that occurred in the month of November, including several approvals for hematologic malignancies.

Rafi Ahmed, PhD, of Emory University, and Thomas F. Gajewski, MD, PhD, of the University of Chicago, received the highest honors from the Cancer Research Institute for their fundamental contributions to the fields of immunology and cancer immunotherapy during the Institute’s 31^st Annual Awards Dinner on Tuesday, November 14, at The Plaza Hotel in New York City.

Louis M. Weiner, MD, has been selected by MedStar Health to be director of its MedStar Georgetown Cancer Institute, leading development and coordination of clinical care and research across the MedStar Health system. He will manage programs focusing on prevention, treatment, rehabilitation, survivorship, and end-of-life care.

The Leukemia & Lymphoma Society (LLS) has awarded Barbara Savoldo, MD, PhD, with a $600,000, 3-year grant in support of her promising research into a CAR T-cell treatment with a “safety switch” that could alleviate potential side effects for patients with acute lymphoblastic leukemia being treated with the immunotherapy.

The FoundationOne CDx (F1CDx) cancer biomarker assay has been granted FDA approval concurrently with a decision from the Centers for Medicare & Medicaid Services to provide insurance coverage for the next-generation sequencing NGS-based in vitro diagnostic test.

Tim G. Larson, MD, discusses emerging data involving immunotherapy for patients with microsatellite instability (MSI)/microsatellite stable (MSS) CRC and highlights some of the identified molecular mutations in patients with CRC.

A. David McCollum, MD, discusses&nbsp;the optimal management of CRC in the first-line setting and the ongoing research with checkpoint inhibitors designed to benefit larger groups of patients.<br /> &nbsp;

According to results of a survey reported at the European Society of&nbsp;Gynaecological Oncology 2017 Congress, patients with ovarian cancer are more likely to opt to receive maintenance therapy if it could offer delay of disease progression and allow them to maintain or improve their quality of life.

Jonathan Ledermann, MD, discusses results of the phase III ARIEL3 study, as well as the future of PARP inhibitors in the maintenance setting for patients with ovarian cancer.

Niraparib&nbsp;(Zejula) has been approved by the European Commission as a maintenance therapy for women with platinum-sensitive relapsed high-grade serous&nbsp;epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, Tesaro, the manufacturer of the treatment, has announced.

In findings from the phase III JAVELIN Gastric 300 trial, survival was not improved with the anti&ndash;PD-L1 agent avelumab compared with chemotherapy in previously treated patients with gastric&nbsp;or gastroesophageal junction adenocarcinoma.<br /> &nbsp;

In patients with&nbsp;hepatocellular carcinoma (HCC), pill burden and treatment costs were reduced, with a trend toward improved treatment completion, by lowering the dose of&nbsp;sorafenib (Nexavar), according to results from a&nbsp;retrospective, multi-institutional study.

Carlos Becerra, MD, discusses&nbsp;the current management and emerging therapies for patients with pancreatic cancer.

Renowned scientist Ramon Parsons, MD, PhD, has been awarded an Outstanding Investigator Award (OIA) from the National Cancer Institute. The award guarantees $6.7 million for 7 years of research into the tumor-suppressing functions of the <em>PTEN</em> gene, which he discovered.

Laura J. van&rsquo;t Veer, PhD, discusses&nbsp;determining more accurate methods of treatment for patients with early- and late-stage breast cancer based on advances in genetic testing, specifically the 70-gene prognostic signature.

Lajos Pusztai, MD,&nbsp;discusses neoadjuvant and adjuvant treatment decisions for patients with HER2-positive breast cancer, as well as the potential of immunotherapy in the metastatic setting.<br /> &nbsp;

A biologics license application for mogamulizumab has been granted a priority review by the FDA for the&nbsp;treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy,&nbsp;Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody, has announced.

According to results from the phase II&nbsp;NCI9855 study, presented at&nbsp;the 2017 World Congress of Melanoma, glembatumumab vedotin (CDX-011) induced a 61%&nbsp;disease control rate in patients with&nbsp;metastatic uveal melanoma, despite a low a low objective response rate of 6%.

For patients with advanced cancers, including melanoma,&nbsp;non&ndash;small cell lung cancer, and renal cell carcinoma, the combination of the CD122-biased cytokine&nbsp;NKTR-214&nbsp;and the PD-1 inhibitor nivolumab (Opdivo) demonstrated target lesion reductions of 72%,&nbsp;according to findings from the phase Ib PIVOT-02 trial presented at the 2017 SITC Annual Meeting.

According to findings presented at the 2017 World Conference on Lung Cancer, the&nbsp;potent and selective inhibitor of ROS1 and TRKentrectinib induced an objective response rate of 68.8% by blinded independent central review, which included 2 complete responses (6.3%), for patients with <em>ROS1</em> fusion-positive advanced non&ndash;small cell lung cancer.

According to results of a phase I/II study, men with metastatic castration-resistant prostate cancer who received a second course of radium-223&nbsp;(Xofigo) experienced minimal hematologic toxicity and low radiographic bone progression rates.

The American Society of Hematology has announced that James R. Downing, MD, of St. Jude Children&rsquo;s Research Hospital will be awarded the 2017 E. Donnall Thomas Lecture and Prize for his discoveries related to the hematopathology and molecular biology of childhood leukemia.

AstraZeneca has submitted a&nbsp;supplemental new drug application to Japan&#39;s&nbsp;Pharmaceuticals and Medical Devices Agency for the use of the&nbsp;third-generation, irreversible EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) in the frontline treatment of patients with&nbsp;inoperable or recurrent <em>EGFR</em>-positive non&ndash;small cell lung cancer.

Suresh A. Ramalingam, MD,&nbsp;discusses some of the changes to the NCCN guidelines in NSCLC, specifically with <em>EGFR</em>-mutation&ndash;positive disease, and how the frontline recommendation of osimertinib will impact clinical practice.

George R. Blumenschein, MD,&nbsp;discusses the current treatment landscape for patients with squamous cell lung cancer.

Richard S. Finn, MD, highlights the evolution of CDK 4/6 inhibition in the field of breast cancer and appropriate patient selection for this type of therapy.

Ribociclib (Kisqali) met its primary endpoint for progression-free survival (PFS) in premenopausal women with&nbsp;hormone-receptor (HR)&ndash;positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer, according to topline results from the MONALEESA-7 trial, Novartis recently announced in a press release.

Three members will lead the American Society of Hematology (ASH) Executive Committee with terms beginning after the 2017 ASH Annual Meeting, which will be held December 9 to 12 in Atlanta, Georgia: Stephanie Lee, MD; Agnes Lee, MD; and Joseph Mikhael, MD.

In data presented at the 2017 ESMO Asia Congress, updated results again sustained the benefit of frontline osimertinib (Tagrisso) in patients with <em>EGFR</em>-positive advanced non&ndash;small cell lung cancer (NSCLC) and CNS metastases at baseline.

After granting a priority review to durvalumab (Imfinzi) in October for the treatment of patients&nbsp;with stage III, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation, the FDA is now reviewing results from the phase III PACIFIC trial, which have now&nbsp;been published in the print edition of the New England Journal Medicine.