News

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 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.

According to&nbsp;Raoul S. Concepcion, MD, FACS, the field of&nbsp;castration-resistant prostate cancer continues to progress with new treatment options; next steps include tailoring these new treatment strategies to individual patients.

Andre Goy, MD,&nbsp;discusses some of the recent changes that have been seen in the treatment landscape for patients with MCL and some of the ways these subsets of patients are being identified in order to find the best treatment option for an individual patient.

Joseph F. Stilwill, MD,&nbsp;shares insight on the benefit seen with CDK4/6 inhibitors in patients with advanced HR-positive, HER2-negative breast cancer and highlighted ongoing research aimed at overcoming acquired resistance.

The highly selective JAK2 inhibitor fedratinib has received a priority review designation by the FDA&nbsp;as a treatment for patients with myelofibrosis. The designation was granted based on findings from the&nbsp;phase III JAKARTA and phase II JAKARTA-2 trials.

Scott T. Tagawa, MD,&nbsp;discusses the potential of sacituzumab govitecan in advanced urothelial cancers and reflected on progress made in prostate cancer.

Jean-Jacques Kiladjian, MD, PhD, discusses 2 clinical trials evaluating the use of ruxolitinib in patients with polycythemia vera and myelofibrosis.

Hope Rugo, MD,&nbsp;discusses results from a trial that evaluated a reduced dose of palbociclib in patients with HR+ metastatic breast cancer. She also shares details from research for a scalp cooling cap to reduce hair loss for patients with breast cancer.

Jacqueline C. Barrientos, MD, MS, discusses emerging agents and combinations in CLL based on recent trial data.

The combination of lenvatinib plus pembrolizumab induced responses in a quarter of patients with urothelial carcinoma, according to the results of a small study presented at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. The immunotherapy/targeted therapy combination also demonstrated a manageable toxicity profile.

Richard M. Stone, MD,&nbsp;discusses emerging agents and combinations for older patients with AML, along with his preferences for treatment.

The phase III FORWARD I trial fell short of its primary endpoint, as findings showed the antibody-drug conjugate mirvetuximab soravtansine did not result in a&nbsp;progression-free survival improvement compared with&nbsp;chemotherapy&nbsp;in patients with folate receptor alpha&ndash;positive, platinum-resistant ovarian cancer and in an overall patient population.

A look back at all the FDA news in oncology from the month of February 2019, including several new approvals, priority review designations, and an orphan drug desgination.

During a <em>Targeted Oncology </em>live case-based peer perspectives program, Ruth He, MD, PhD, discussed her strategies for treating patients with liver cancer as more therapeutic options enter the landscape.