News

Based on findings from the APHINITY trial, pertuzumab (Perjeta) has been approved by the FDA in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk for recurrence.

Nivolumab (Opdivo) has received FDA approval for the adjuvant treatment of patients with completely resected melanoma with lymph node involvement or metastatic disease.

In a recent open-label phase II study, denosumab (Xgeva) demonstrated favorable results in patients with resectable giant cell tumor of bone (GCTB). More than one-third of the trial patients avoided surgery and nearly half had less morbidity with surgery when treated with denosumab.

Several agents are being investigated for the treatment of patients with glioblastoma in an ongoing phase II clinical trial. Known as the INdividualized Screening Trial of Innovative Glioblastoma Therapy, the study will randomize patients to 1 of 4 arms—either the control arm of standard-of-care agent temozolomide, or 1 of 3 experimental arms.

According to findings from the phase I SCOUT trial, the novel pan-TRK inhibitor larotrectinib (LOXO-101)&nbsp;achieved a 93% response rate in pediatric patients with <em>TRK</em>&nbsp;fusion&ndash;positive solid tumors.

Bosutinib (Bosulif) has been approved by the FDA as a first-line treatment for&nbsp;patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).

Based on results of the CABOSUN trial, cabozantinib&nbsp;(Cabometyx) has been approved by the FDA for previously untreated patients with advanced renal cell carcinoma.

Brian Van Tine, MD,&nbsp;discusses the recent discoveries made for the treatment of soft tissue sarcoma and the ongoing trials for this patient population. &nbsp;&nbsp;

In patients with&nbsp;chronic lymphocytic leukemia (CLL), the addition of ibrutinib to standard frontline chemoimmunotherapy induced negative minimum residual disease (MRD) status in bone marrow for 83% of patients, according to results from a preliminary clinical study presented at the 2017 ASH Annual Meeting.

Rapid and durable responses were induced with the combination of selinexor, weekly bortezomib (Velcade), and low-dose dexamethasone (Vd), according to results of a dose escalation/expansion trial of patients with relapsed/refractory multiple myeloma (RRMM) presented at the 2017 ASH Annual Meeting.

A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA&nbsp;as a first-line treatment for patients with non&ndash;small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).

After 4 years of follow-up, a majority of patients with polycythemia vera (PV) that responded to treatment with ruxolitinib (Jakafi) maintained their responses, results from a randomized trial showed.

According to phase II findings from the MEDIOLA trial presented at the 2017 San Antonio Breast Cancer Symposium,&nbsp;the combination of olaparib and durvalumab demonstrated a disease control rate of 80% for pretreated patients with germline <em>BRCA-</em>mutated, HER2-negative metastatic breast cancer, according to phase II findings from the MEDIOLA trial.

According to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium,&nbsp;the combination of abemaciclib and pembrolizumab showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer.

George P. Kim, MD, recently shared the treatment considerations and decisions he makes when treating patients with metastatic pancreatic cancer. Kim, a medical oncologist at 21st Century Oncology in Jacksonville, Florida, explained his treatment decisions based on 2 case scenarios during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.

Based on findings of the phase III CheckMate-214 trial, a&nbsp;supplemental biologics license application for the combination of nivolumab and&nbsp;ipilimumab has been granted a priority review by the FDA&nbsp;as a frontline treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma.

Michael Wang, MD,&nbsp;discusses the impact of acalabrutinib on patients with MCL, ongoing progress in the field, and The University of Texas MD Anderson Cancer Center&rsquo;s Lymphoma Moonshot Program.

Andre Goy, MD, shed light on some of these studies as well as future treatment options for patients with MCL.

Eli Lilly and Company has announced that Kimberly L. Blackwell, MD, a pioneer in breast cancer research, will serve as its vice president of early phase development and immuno-oncology. She will begin her new role on March 12, 2018.<br /> &nbsp;

According to research recently reported at the&nbsp;European Society of Gynaecological Oncology 2017 Congress, deleterious mutations in the PALB2 gene may account for development of breast cancer in women with an elevated risk due to a family history of breast or ovarian cancer, but who test negative for the BRCA1 or BRCA2 genes.

Lori Goldstein, MD, FASCO, is among 27 breast oncologists across the country to be recognized by <em>Forbes&rsquo; </em>&ldquo;Physician Honor Role&rdquo;<em> </em>as an extraordinary physician in the field of oncology.

Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of&nbsp;adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck,&nbsp;the manufacturer of pembrolizumab. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.

CMB305, an immunotherapy regimen that generates and expands anti&ndash;NY-ESO-1 T cells, demonstrated a favorable survival rate compared with other approved agents for recurrent soft tissue sarcoma, according to results presented at the 2017 ASCO Annual Meeting.

Alan P. Venook, MD, recently discussed 2 cases of patients with colorectal cancer, and the treatment treatment considerations and decisions he would make when treating these patients. Venook, Shorenstein Associate Director for Program Development, Helen Diller Family Comprehensive Cancer Center, and professor, Department of Medicine, University of California San Francisco, discussed these cases during a&nbsp;<em>Targeted Oncology</em>&nbsp;live case-based peer perspectives dinner.<br /> &nbsp;

Based on results from the phase III ARIEL3 trial, in which maintenance rucaparib improved median progression-free survival by 11.2 months versus placebo for patients with&nbsp;<em>BRCA</em>-mutant platinum-sensitive ovarian cancer, the FDA has granted the PARP inhibitor a priority review.

After previously receiving an accelerated approval, bevacizumab (Avastin) has been granted a full approval by the FDA for the treatment of&nbsp;adult patients with glioblastoma that progressed following prior therapy,&nbsp;according to Genentech, the manufacturer of the VEGF inhibitor.

The partial clinical holds placed on the&nbsp;phase I CheckMate-039 and phase II CA204142 trials in October were lifted today by the FDA. Both trials were exploring&nbsp;nivolumab-based regimens in patients with relapsed/refractory multiple myeloma.

Dan T. Vogl, MD,&nbsp;discusses some of the novel agents being investigated alone and in combination in multiple myeloma. He also highlighted the potential with CAR T-cell therapy in the multiple myeloma paradigm.

Michael A. Caligiuri, MD, has been appointed president and physician-in-chief of the City of Hope National Medical Center, a position which will go into effect in February 2018.

Daratumumab (Darzalex) has been submitted for FDA approval for&nbsp;use in combination with bortezomib (Velcade), melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).