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) for the first-line treatment of patients with <em>ALK</em>-positive advanced non­–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 />
The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) has been approved by the FDA for the treatment of patients with <em>BRAF</em> V600–positive advanced or metastatic non–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, 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–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 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 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 <em>ALK</em>-positive non–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 biologics license application (BLA) for epoetin hospira (Retacrit), an epoetin alfa (Epogen/Procrit) biosimilar manufactured by Hospira, was recommended for approval by the FDA’s Oncologic Drugs Committee voted (ODAC) 14-1 today.
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 human papillomavirus (HPV) vaccine continue to be impressive, with newly reported findings showing it reduced 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 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>