Jason Harris

In a 6-1 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approving gemtuzumab ozogamicin in combination with daunorubicin and cytarabine for the treatment of patients with newly-diagnosed CD33-positive acute myeloid leukemia.

In patients with advanced melanoma enrolled in the phase III CheckMate-238 trial, adjuvant nivolumab extended recurrence-free survival compared with adjuvant ipilimumab.

Updated phase II results from the KEYNOTE-052 trial showed that first-line treatment with pembrolizumab produced a long-lasting response for patients with cisplatin-ineligible advanced urothelial cancer.

A clinical hold has been placed on the phase III KEYNOTE-183 and KEYNOTE-185 pembrolizumab trials and the discontinuation of the lenalidomide/dexamethasone/pembrolizumab arm of the KEYNOTE-023 trial has been ordered by the FDA.

Rucaparib improved progression-free survival versus placebo as a maintenance treatment for women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer, according to results from the phase III ARIEL3 trial.

Ceritinib has been approved by the European Union (EU)&nbsp;for the first-line treatment of patients with <em>ALK</em>-positive advanced non&shy;&ndash;small cell lung cancer.

Ribociclib has been recommended for approval by the Committee for Medicinal Products for Human Use, a part of the European Medicines Agency, for use in combination with an aromatase inhibitor as a first-line treatment for postmenopausal women with HR-positive /HER2-negative locally advanced or metastatic breast cancer.<br /> &nbsp;

The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) has been approved by the FDA for the treatment of patients with <em>BRAF</em> V600&ndash;positive advanced or metastatic non&ndash;small cell lung cancer (NSCLC).

The FDA has granted orphan drug designation to its EZH2-inhibitor tazemetostat for the treatment of adults with INI1-negative epithelioid sarcoma,&nbsp;Epizyme has announced.

The antibody-drug conjugate sacituzumab govitecan was well-tolerated and produced a median duration of response of 6.0 months in previously treated patients with metastatic non&ndash;small cell lung cancer.

Options for treating patients with hepatocellular carcinoma may currently be limited, with most physicians turning to a tyrosine kinase inhibitor for advanced disease, but physicians may soon be able to choose between a TKI and immunotherapy.

Merck has announced that enrollment for the phase III KEYNOTE-183 and KEYNOTE-185 multiple myeloma trials has been postponed due to deaths in patients treated with pembrolizumab.

Six to 9 months of treatment with neoadjuvant imatinib (Gleevec) was a promising treatment for patients with large gastric gastrointestinal stromal tumors (GIST), according to the results of a small multinational study in Asian patients.

Drug manufacturer XBiotech has cancelled the phase III XCITE study of MABp1 (Hutruo; formerly Xilonix) in patients with advanced colorectal cancer, following a second prospectively planned, unblinded analysis.

The FDA has scheduled a public hearing of its&nbsp;Oncologic Drugs Advisory Committee (ODAC) to address a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The hearing is planned for July 12, 2017.

Treatment with&nbsp;chimeric antigen receptor (CAR) T cells that target B-cell maturation protein (BMCA) achieved clinical remissions in 33 out of 35 patients (94%) with relapsed or refractory multiple myeloma in early results from a Chinese study presented at the 2017 ASCO Annual Meeting.

Second-generation ALK inhibitor alectinib (Alecensa) demonstrated a 15-month improvement in progression-free survival compared with crizotinib (Xalkori), the first-generation ALK inhibitor and standard of care, in patients with&nbsp;<em>ALK</em>-positive non&ndash;small cell lung cancer.

A new, high-intensity genomic sequencing approach for circulating tumor DNA uncovered at least 1 genetic change in both the tumor DNA and the blood of 89% of patients, demonstrating a high rate of concordance between 2 approaches for detecting molecular aberrations, according to a study presented at the 2017 ASCO Annual Meeting.

A single course of radiation treatment could relieve the symptoms of a spinal cord compression and maintain mobility as effectively as a multifractional course of radiotherapy (RT) in patients with advanced cancer, according to the results of a large phase III trial.

A new drug application from Jazz Pharmaceuticals has been accepted by the FDA for a novel CPX-351 injection (Vyxeos) for the treatment of acute myeloid leukemia.

The addition of ramucirumab to docetaxel led to a statistically significant improvement in progression-free survival versus docetaxel alone in previously treated patients with locally advanced or unresectable or metastatic urothelial carcinoma.

The approval of a&nbsp;biologics license application (BLA) for&nbsp;epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira, was recommended for approval by the&nbsp;FDA&rsquo;s Oncologic Drugs Committee voted (ODAC) 14-1 today.&nbsp;

Pembrolizumab (Keytruda) has been granted a priority review by the FDA for the treatment of patients who have undergone at least 2 courses of chemotherapy for recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.

Bevacizumab demonstrated superior progression-free survival and a trend toward improved overall survival (OS) in patients with proliferative or mesenchymal ovarian tumors compared with patients with immunoreactive or differentiated tumors.

Efficacy results for the&nbsp;human papillomavirus (HPV) vaccine continue to be impressive, with newly reported findings showing it reduced&nbsp;the prevalence of high-risk oral HPV infections by 88% in young adults who had at least 1 dose of the vaccine.

Subcutaneous administration of rituximab (Rituxan) produced nearly identical response rates and toxicity as IV administration in the first-line treatment of follicular lymphoma.

A strong association was found between high PD-L1 expression and local failure following radiotherapy in HPV-negative head and neck squamous cell carcinomas.

Adding bevacizumab to standard platinum-based chemotherapy demonstrated a clinically significant improvement in median overall survival in women with recurrent ovarian cancer.

Median overall survival was not improved with&nbsp;zoptarelin doxorubicin, a hybrid molecule combining an LHRH-agonist and doxorubicin, in a phase III advanced endometrial cancer trial.

Women who underwent bariatric surgery to combat obesity were less likely to develop any cancer and also less likely to develop female-specific cancers, acording to study results published in <em>Gynecologic Oncology.</em>