News

In response to a biologics license application submitted for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, the FDA has issued a complete response letter to Immunomedics, citing chemistry, manufacturing, and control matters.

At practices with their own pharmacies, many patients are now given the option of picking up prescriptions directly from the clinic, known as medically integrated dispensing. Proponents of this method believe that it provides for better patient outcomes, allows for better tracking of patient adherence, and is substantially more cost effective. 

Gabriela S. Hobbs, MD, discusses recent advances in the treatment of myelofibrosis and other MPNs, as well as clinical trials she is currently working on in this space.

Srdan Verstovsek, MD, PhD, discusses the current treatment landscape for patients with essential thrombocytopenia and polycythemia vera and shared details of ongoing clinical trials in the field.

A supplemental biologics license application submitted to the FDA for atezolizumab, carboplatin, and nab-paclitaxel has been accepted. The application, based on findings from the phase III IMpower130 trial, is seeking the agent's approval for patients with metastatic nonsquamous non–small cell lung cancer.

John O. Mascarenhas, MD, discusses with&nbsp;<em>Targeted Oncology&nbsp;</em>the&nbsp;recent advancements being made in the treatment of patients with advanced myelofibrosis and highlights some of the unmet needs that still exist within this space.

Eribulin mesylate (Halaven) demonstrated efficacy in the first-line for patients with aggressive HER2-negative metastatic breast cancer that have received prior treatment with a taxane in the (neo)adjuvant setting, according to results from the phase II MERIBEL trial.

The&nbsp;investigational BTK inhibitor zanubrutinib (BGB-3111) has received a breakthrough therapy designation from the FDA&nbsp;for the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 prior therapy,&nbsp;BeiGene, the company manufacturing the agent, has announced.

A randomized phase II trial found that nab-paclitaxel showed equivalent efficacy and was well tolerated compared with docetaxel as neoadjuvant therapy in early-stage breast cancer.

ASLAN Pharmaceuticals, the company developing varlitinib (ASLAN001), has announced that a phase II frontline trial investigating the&nbsp;pan-HER inhibitor added to mFOLFOX6 in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer has missed its primary endpoint.

Cabozantinib has been approved by the FDA for the treatment of&nbsp;patients with hepatocellular carcinoma who previously received sorafenib, Exelixis, the company developing the agent, announced today.

Krish Patel, MD,&nbsp;discusses some of the most significant mantle cell lymphoma data presented during the 2018 ASH Annual Meeting and how the use of BTK inhibitors will evolve going forward.

Autologous hematopoietic cell transplantation consolidation after induction therapy may improve progression-free survival in younger, fit patients with mantle cell lymphoma, according to the results of a retrospective analysis recently published in the <em>Journal of Clinical Oncology. </em>

Pashtoon M. Kasi, MD, MBBS, MS,&nbsp;discusses recent advances with individualized medicine in CRC, as well as the unmet needs that still exist in this area.

Jonathon B. Cohen, MD, MS, discussed his treatment considerations and decisions for treating patients with mantle cell lymphoma. Cohen made these decisions based on a case scenario of a patient with advanced-stage MCL.

Neoadjuvant chemotherapy with a dose-dense, or accelerated, course of methotrexate, vinblastine, doxorubicin, and cisplatin was more likely to produce a complete pathologic response and extend overall survival than any other chemotherapy regimen in patients with bladder cancer treated with cystectomy, according to a study published in <em>JAMA Oncology</em>.

This week the FDA granted a fast track designation to the novel targeted therapy vofatamab for the treatment of patients with advanced or metastatic urothelial carcinoma who harbor an <em>FGFR3 </em>alteration, according to Rainier Therapeutics, the company developing vofatamab.

Joaquim Bellmunt, MD, PhD, discusses recent immunotherapy advancements in bladder cancer and what future research will look like.

Jordan Gauthier, MD, MSc, discussed the results presented at the 2018 ASH Annual for this clinical trial and where the research is headed for patients with CLL. He also highlights another promising combination for this patient population that was presented at the meeting as well.

A triplet regimen consisting of chlorambucil and rituximab in combination with an individualized dose of lenalidomide can potentially be used as a frontline treatment for patients with advanced chronic lymphocytic leukemia who are older or unfit for standard treatment with fludarabine, cyclophosphamide, and rituximab.

Due to the significant decline in smoking and an increase in advances for early cancer detection and screening, the cancer death rate has declined 27% in the United States from 1991 to 2016, according to the American Cancer Society&rsquo;s annual report on cancer rates.

UroGen has announced topline findings from the&nbsp;ongoing phase III OLYMPUS trial, in which the investigational mitomycin formulation UGN-101 (mitomycin gel) demonstrated a 57% complete response rate in patients with&nbsp;low-grade upper-tract urothelial cancer.

Maria-Victoria Mateos, MD, PhD, discusses updated findings from the ALCYONE trial in patients with newly diagnosed multiple myeloma.&nbsp;

Cristina Gasparetto, MD, discusses findings from an ongoing trial of&nbsp;selinexor, daratumumab, and dexamethasone in patients with multiple myeloma

Eli Lilly and Company will acquire Loxo Oncology for an estimated&nbsp;$8 billion in cash, the company has announced.

An ongoing randomized phase III clinical trial is investigating the safety and efficacy of&nbsp;atezolizumab compared with placebo as an adjuvant treatment after definitive local therapy in patients with high-risk, locally advanced squamous cell carcinoma of the head and neck.

Kerry A. Rogers, MD,&nbsp;discusses phase II findings with obinutuzumab, ibrutinib, and venetoclax and the future of dose-limited regimens in CLL.

C. Ola Landgren, MD, PhD,&nbsp;discusses the role of MRD negativity and the emergence of CAR T-cell therapy in multiple myeloma.

Findings of a recent study suggest HPV testing should be incorporated into cervical cancer screening programs. The&nbsp;nested case-control Swedish study&nbsp;found that the presence of&nbsp;specific subtypes of HPV, namely HPV-16 and -18, were associated&nbsp;with a higher risk of developing high-grade cervical intraepithelial neoplasia in women under the age of 30.

According to recently announced topline findings, the confirmatory phase III SOLO-3 trial of&nbsp;olaparib has met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in&nbsp;objective response rate in patients with <em>BRCA</em>-mutant ovarian cancer who have relapsed on at least 2 prior lines of therapy