News

Robert L. Coleman, MD, discusses targeting tumor vasculature and angiogenesis in ovarian cancer.

Pembrolizumab (Keytruda) has been approved in Japan for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.

Based on results of the Ib/II Study 111, the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib has been granted a breakthrough therapy designation by the FDA for the treatment of patients with advanced and/or metastatic renal cell carcinoma.

The American Society of Hematology (ASH) has announced that Alexis A. Thompson, MD, MPH, has taken up the helm as its president for 2018. She will serve for a 1-year term through December 2018.

The oncology community has lost a pioneer in the integration of humanity into cancer care: Jimmie C. Holland, MD, known as the mother of psychosocial oncology.<br /> &nbsp;

Arjun Balar, MD,&nbsp;discusses novel immunotherapy combinations for the treatment of patients with bladder cancer.

Based on data from the phase III 482 study, denosumab (Xgeva) has been granted FDA approval for&nbsp;the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.

Eltrombopag (Promacta) has been granted a breakthrough therapy designation by the FDA for use&nbsp;in combination with standard immunosuppressive therapy&nbsp;for the first-line treatment of patients with severe aplastic anemia.

Hussein A. Tawbi, MD,&nbsp;discusses the considerations he makes when choosing between immunotherapy and targeted therapy for patients with melanoma and how long-term targeted therapy data can influence treatment decisions.<br /> &nbsp;

Richard D. Carvajal, MD,&nbsp;discusses considerations when diagnosing and treating extracutaneous melanomas and the importance of treating such diseases differently than the more commonly seen melanomas.

Miami Cancer Institute at Baptist Health will leverage Cota&rsquo;s data, nodal address and analytics to deliver precision medicine and enable the best treatments at the highest quality of care for patients<br /> &nbsp;

The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

Based on results of the phase III MONALEESA-7 trial,&nbsp;ribociclib (Kisqali) has been granted a breakthrough therapy designation by the FDA for use in combination with&nbsp;tamoxifen or an aromatase inhibitor as frontline treatment for pre- or perimenopausal women with hormone receptor&ndash;positive, HER2-negative advanced or metastatic breast cancer.

Based on findings from the phase III ECHELON-1 trial, a&nbsp;supplemental biologics application (sBLA) for&nbsp;brentuximab vedotin (Adcetris)&nbsp;in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of&nbsp;advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.

A new drug application for the novel version of the&nbsp;radiopharmaceutical iobenguane I-131 (Azedra) has been granted a priority review by the FDA for the treatment of patients with malignant or recurrent&nbsp;pheochromocytoma or paraganglioma,&nbsp;according to a statement from Progenics Pharmaceuticals, the company developing the novel iodine-131 metaiodobenzylguanidine.

Michael A. Morse, MD,&nbsp;explained his treatment decisions in 1 patient with metastatic colorectal cancer who progresses and requires second-line treatment during a&nbsp;recent <em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Regardless of smoking history, patients with cancer of the lung harboring specific genetic alterations who were treated with targeted therapies experienced longer survival than those patients who did not receive targeted treatment, according to results of a multi-institutional extension study&nbsp;to identify and treat oncogenic driver events.

The proteasome inhibitor ixazomib has received a recommendation from the United Kingdom&#39;s National Institute for Health and Care Excellence for patients with relapsed/refractory multiple myeloma.

Based on results of a phase I trial presented at the 2017 ASH Annual Meeting, a new drug applicaton for ivosidenib has been submitted for FDA approval for the treatment of patients with&nbsp;relapsed/refractory IDH1-mutant acute myeloid leukemia, according to a statement from Agios Pharmaceuticals, the company developing the targeted therapy.

The label for nilotinib (Tasigna) has been updated by the FDA with a provision stating patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who have received the BCR-ABL tyrosine kinase inhibitor could be eligible to stop treatment after having recieved for at least 3 years and having achieved the specific predetermined criteria.<br /> <br /> &nbsp;

Based on findings from a 17-patient study, a novel breast-specific stereotactic body radiotherapy (SBRT) device known as GammaPod has been approved by the FDA as a treatment for patients with early breast cancer.<br /> <br /> &nbsp;

Hans-Joachim Schmoll, MD,&nbsp;discusses updated CHARTA findings, the current role of chemotherapy in patients with metastatic CRC, and his predictions for the future CRC treatment landscape.

Leonard Saltz, MD,&nbsp;highlights the current go-to therapies and overarching questions for mCRC treatment.

Shubham Pant, MD,&nbsp;discusses therapeutic options for patients with metastatic CRC, while&nbsp;stressing the importance of clinical trials as an avenue to establish more novel treatment decisions in this setting.

Based on findings of the&nbsp;phase III COMBI-AD study, a supplemental new drug application for&nbsp;dabrafenib (Tafinlar) combined with trametinib (Mekinist)&nbsp;has been granted a priority review by the FDA&nbsp;as an adjuvant treatment for patients with <em>BRAF</em> V600E&ndash; or V600K&ndash;positive stage III melanoma following complete resection.

A novel kinase switch control inhibitor, DCC-2618, demonstrated an encouraging disease control rate (DCR) of 76% at 12 weeks in heavily pretreated patients with gastrointestinal stromal tumors (GIST) treated with a daily &ge;100-mg dose, according to findings of a phase I first-in-human, dose-escalation trial.

The PD-L1 inhibitor avelumab (Bavencio) has been granted a breakthrough therapy designation by the FDA&nbsp;for use in combination with the VEGF inhibitor axitinib (Inlyta) in treatment-na&iuml;ve patients with advanced renal cell carcinoma.

For patients with high-risk melanoma, the area of adjuvant treatment has seen little progress until recently. In large part, this is due to the lack of&nbsp;consensus in the community on what treatments to use, when to use them, and in which patients to implement them, explains Michael B. Atkins, MD.

Michael A. Postow, MD, discusses the evolution of combination therapies for patients with melanoma.

Based on data from the phase III SPARTAN trial, apalutamide has been granted a priority review by the FDA for the&nbsp;treatment of patients with nonmetastatic castration-resistant prostate cancer, according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.