News

The biologics license application for eflapegrastim was voluntarily withdrawn by Spectrum Pharmaceuticals as the company requires more time to complete additional manufacturing-related information requested by the FDA.

Ofatumumab was both active and well-tolerated at 2 different dose levels in treatment-na&iuml;ve patients with advanced follicular lymphoma who had low tumor burden, according to findings from a phase II, multicenter study recently published in the <em>British Journal of Haematology</em>.

Ahead of the 50th Annual SGO Meeting, Shannon Westin, MD discussed the key takeaways from a case chat and highlighted some data she is looking forward to at the meeting for patients with recurrent ovarian cancer. She also highlighted other data that will play an important part in this treatment landscape and for patients with recurrent cervical cancer.

Based on 2 case scenarios, H. Jack West, MD, discusses treatment options and the data that support these options for the management of squamous and nonsquamous non&ndash;small cell lung cancer.

Following a recommendation from the&nbsp;Oncologic Drugs Advisory Committee against the accelerated approval of&nbsp;selinexor for the treatment of patients with penta-refractory multiple myeloma, the FDA has added&nbsp;3 months to the review period for the new drug application,&nbsp;making the new action date July 6, 2019.

The treatment paradigm for&nbsp;HER2-positive breast cancer may be reshaped over the next several years, as head-to-head studies comparing new agents to the current standard of care begin to yield results,&nbsp;said Sara A. Hurvitz, MD.

Diagnosis, risk stratification, and the management of patients with polycythemia vera and myelofibrosis have all been significantly improved by the inclusion of a greater understanding of the clinical and molecular characteristics of these 2 different myeloproliferative neoplasms, according to Abdulraheem Yacoub, MD.

During a <em>Targeted Oncology </em>live case-based peer perspectives presentation, Kartik Konduri, MD, recently discussed the treatment considerations and decisions he makes when treating patients with non&ndash;small cell lung cancer.

Paul J. Shaughnessy, MD,&nbsp;discusses updates in stem cell mobilization and transplant for DLBCL, including the potential for CAR T-cell therapy to supplant autologous stem cell transplant.

The need for new therapies to treat&nbsp;metastatic triple-negative breast cancer is pressing, and the development of&nbsp;antibody-drug conjugates represents a promising new strategy for these patients,&nbsp;according to Aditya Bardia, MD, MPH.

Robert L. Ferris, MD, PhD, Co-Physician Editor in Chief, <em>Targeted Therapies in Oncology</em>,<em>&nbsp;</em>discusses<em>&nbsp;</em>the<em>&nbsp;</em>evolving<em>&nbsp;</em>role of immunotherapy in melanoma and non&ndash;small cell lung cancer, where by it is now the dominant therapeutic approach in these diseases in progressively earlier lines of therapy.

A rolling submission has been completed to the FDA for the potential approval of the combination of daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone (DRd)&nbsp;for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Nab-paclitaxel plus gemcitabine in the adjuvant setting did not improve disease-free survival in patients with pancreatic cancer compared to gemcitabine alone, according to topline results from the phase III APACT trial that have been confirmed by independent radiological review.

The Health and Human Services Secretary has announced Norman E. Sharpless, MD, will serve as acting commissioner of the FDA following the resignation of Scott&nbsp;Gottlieb, MD, in April 2019.

At the&nbsp;<em>36th Annual&nbsp;</em>Miami Breast Cancer Conference^&reg;, a panel of experts discussed the use of 2 FDA-approved PARP inhibitors for patients with HER2-negative advanced or metastatic breast cancer whose tumors are positive for germline&nbsp;<em>BRCA1/2&nbsp;</em>mutations.

Progression-free survival, the primary endpoint of the RELAY trial,&nbsp;was significantly improved with frontline&nbsp;ramucirumab in combination with erlotinib compared to placebo plus erlotinib in patients with metastatic&nbsp;<em>EGFR</em>-mutant&nbsp;non&ndash;small cell lung cancer.

A fourth trastuzumab biosimilar has been granted approval by the FDA. The approval was for PF-05280014 for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Jeff Sharman, MD,&nbsp;discusses the implications of real-world ibrutinib findings in mantle cell lymphoma and underscored the need for the development of more effective treatments for this patient population.

A novel Fc-enhanced CD19-targeted antibody, MOR208, is generating interest for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation and is making its way toward a future regulatory filing.

An accelerated approval has been granted by the FDA for the combination of&nbsp;atezolizumab and nab-paclitaxel as a frontline treatment for patients with&nbsp;unresectable locally advanced or metastatic PD-L1&ndash;positive triple-negative breast cancer.

Although prognostic indices for mantle cell lymphoma can be useful in the classification of patients, it does little in guiding treatment decisions. Instead of relying on these indices, Simon Rule, MD, advocates for a watch-and-wait approach to managing certain patients&nbsp;with mantle cell lymphoma.

Genomic testing could increasingly be utilized to guide treatment decisions for Veteran patients with cancer. Two recent announcements confirm an emerging focus from Veterans Affairs on genetic testing that provides more informed and tailored cancer care for US Veterans.

Researchers have defined a clinically and biologically distinct subgroup of tumors within germinal center B-cell&ndash;like diffuse large B-cell lymphoma characterized by a gene expression signature of high-grade B-cell lymphoma with&nbsp;<em>MYC&nbsp;</em>and&nbsp;<em>BCL2&nbsp;</em>and/or&nbsp;<em>BCL6&nbsp;</em>rearrangements, according to a study published in the&nbsp;<em>Journal of Clinical Oncology</em>.

Sagar Lonial, MD,&nbsp;discussed some of the emerging agents for the treatment of patients with late relapse in multiple myeloma.

Eytan M. Stein, MD, sheds light on the current treatment landscape of AML and underscored the importance of molecular monitoring. In addition, he highlights where the field of AML is headed.

The combination regimen of venetoclax and obinutuzumab is seeking FDA approval; a supplemental new drug application has been submitted to the FDA&nbsp;for the combination as a treatment for patients with&nbsp;previously untreated chronic lymphocytic leukemia who also have coexisting medical conditions, according to an announcement from&nbsp;Genentech (Roche).

Abdulraheem Yacoub, MD, discusses the development of interferon and its current role in the management of patients with MPNs.

Consuming a diet rich in fiber could boost immunotherapy response in select patients with melanoma,&nbsp;according to early research findings.

Edward B. Garon, MD,&nbsp;discusses the role of EGFR-targeted therapies in the treatment landscape of NSCLC.

The majority of younger patients ultimately diagnosed with colorectal cancer waited 3 to 12 months to see a doctor after symptoms began and were commonly misdiagnosed with&nbsp;issues such as hemorrhoids, irritable bowel syndrome, and anemia, according to recent findings.